A. Esophageal Disorders

A1. FUNCTIONAL CHEST PAIN

Diagnostic criteria* – Must include all of the following:

1. Retrosternal chest pain or discomfort**
2. Absence of associated esophageal symptoms, such as heartburn and dysphagia
3. Absence of evidence that gastroesophageal reflux disease (GERD)† or non-reflux esophagitis is the cause of the symptom††
4. Absence of disorders of esophagogastric junction (EGJ) function and/or disorders of esophageal peristalsis‡

*Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis, with a frequency of at least once per week despite optimized antisecretory therapy for at least 8 weeks
** Cardiac causes should be ruled out
† Abnormal endoscopy (≥ LA grade B esophagitis) or reflux burden based on reflux testing guided by Lyon Consensus 2.0 criteria
†† Consider mucosal biopsies if chest pain occurs with meals, as this could be a surrogate for dysphagia
‡ Disorders of EGJ function (achalasia, conclusive EGJOO) and/or disorders of peristalsis (absent contractility, hypercontractile esophagus, and DES), except IEM, guided by Chicago Classification (CC) v4.0

A2. FUNCTIONAL HEARTBURN

Diagnostic criteria* – Must include all of the following:

1. Burning retrosternal discomfort
2. No symptom relief despite optimized antisecretory therapy for at least 8 weeks
3. Absence of evidence that GERD** or non-reflux esophagitis is the cause of the symptom**
4. Absence of disorders of EGJ obstruction and/or disorders of esophageal peristalsis†

* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis with a frequency of at least once per week despite optimized antisecretory therapy for at least 8 weeks
** Abnormal endoscopy (≥ LA grade B esophagitis) or reflux burden based on reflux testing guided by Lyon Consensus 2.0 criteria (normal MNBI is supportive of functional heartburn)
† Disorders of EGJ function (achalasia, conclusive EGJ outflow obstruction) and/or disorders of peristalsis (absent contractility, hypercontractile esophagus, and distal esophageal spasm [DES]), except ineffective esophageal motility (IEM), guided by CC v4.0

A3. REFLUX HYPERSENSITIVITY

Diagnostic criteria* – Must include all of the following:

1. Retrosternal burning and/or chest pain
2. Regurgitation and belching are not considered in this definition if they occur by themselves or together
3. Evidence of triggering of symptoms by reflux events
4. Absence of evidence that GERD** or non-reflux esophagitis is the cause of the symptom**
5. Absence of disorders of EGJ obstruction and/or disorders of esophageal peristalsis†

* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis, with a frequency of at least once per week despite optimized antisecretory therapy for at least 8 weeks
** Abnormal acid exposure based on technology and approach, and/or LA grades B or higher esophagitis
† Disorders of EGJ function (achalasia, conclusive EGJOO) and/or disorders of peristalsis (absent contractility, hypercontractile esophagus, and DES), except IEM, guided by CC v4.0

A4. GLOBUS

Diagnostic criteria* – Must include all of the following:

1. Persistent or intermittent, non-painful sensation of a lump or foreign body in the throat with no structural lesion identified on physical examination and laryngoscopy
   1. Occurrence of the sensation between meals
   2. Absence of dysphagia or odynophagia
   3. absence of a gastric inlet patch in the proximal esophagus**
2. Absence of evidence that GERD† or non-reflux esophagitis is the cause of the symptom**
3. Absence of disorders of EGJ obstruction and/or disorders of esophageal peristalsis†

* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis, with a frequency of at least once per week following optimized antisecretory therapy for at least 8 weeks
** Since DGBI requires the lack of a mucosal abnormality, a gastric inlet patch precludes a DGBI diagnosis
† Abnormal endoscopy (≥A grades B esophagitis) or reflux burden based on reflux testing guided by Lyon 2.0 criteria
†† Disorders of EGJ function (achalasia, conclusive EGJOO) and/or disorders of peristalsis (absent contractility, hypercontractile esophagus, and DES), except IEM, guided by CC v4.0

A5. FUNCTIONAL DYSPHAGIA

Diagnostic criteria* – Must include all of the following:

1. Sense of solid and/or liquid foods sticking to, lodging in, or passing abnormally through the esophagus
2. Absence of evidence that esophageal mucosal or structural abnormality is the cause of the symptom**
3. Absence of evidence that gastroesophageal reflux† or non-reflux esophagitis is the cause of the symptom
4. Absence of disorders of EGJ obstruction and/or disorders of esophageal peristalsis††

* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis, with a frequency of at least once per week
** Normal esophagram with a tablet or marshmallow, or normal FLIP may be supportive of functional dysphagia
† Abnormal endoscopy (≥ LA grade B esophagitis) or reflux burden based on reflux testing guided by Lyon Consensus 2.0 criteria
†† Disorders of EGJ function (achalasia, conclusive EGJOO) and/or disorders of peristalsis (absent contractility, hypercontractile esophagus, and DES), except IEM, guided by CC v4.0 (normal solid test meal during HRM may be supportive of functional dysphagia)

B. Gastroduodenal Disorders

B1. FUNCTIONAL DYSPEPSIA*

Diagnostic criteria*

1. Must include one or more of the following:
   1. Bothersome postprandial fullness
   2. Bothersome early satiation
   3. Bothersome epigastric pain
   4. Bothersome epigastric burning

AND

2. No evidence of structural, systemic, or metabolic disease that is likely to explain the symptoms

* Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis
** Must fulfill criteria for B1a (postprandial distress syndrome [PDS]) and/or B1b (epigastric pain syndrome [EPS])

B1a. Postprandial* Distress Syndrome (PDS)

Diagnostic criteria*

1. Must include one or both of the following at least 2 days per week:
   1. Bothersome postprandial fullness (i.e., severe enough to impact on usual activities)
   2. Bothersome early satiation (i.e., severe enough to prevent finishing a regular-sized meal)
2. In the presence of 1.1 and/or 1.2, other bothersome symptoms that are elicited or worsened by food ingestion are part of PDS (i.e., postprandial epigastric pain or burning, postprandial nausea, postprandial upper abdominal bloating, or postprandial excessive belching)
3. Predominant nausea and/or persisting vomiting excludes the diagnosis of PDS**
4. Heartburn is not a gastroduodenal symptom but often coexists
5. No evidence of structural, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations

*Postprandial means symptoms that are triggered within 2 hours of meal intak
**Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

B1b. Epigastric* Pain Syndrome (EPS)

Diagnostic criteria*

1. One or both of the following symptoms at least 1 day a week:
   1. Bothersome epigastric pain (i.e., severe enough to affect usual activities)
   2. Bothersome epigastric burning (i.e., severe enough to affect usual activities)
2. Both 1.1 and 1.2 can be induced or worsened postprandially, or occur independently from meal ingestion†
3. PDS criteria are not fulfilled
4. Predominant nausea and/or persisting vomiting excludes the diagnosis of EPS††
5. Heartburn is not a gastroduodenal symptom but often coexists
6. No evidence of structural, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations

* Limited to the central part of the abdomen above the navel
** When epigastric pain and/or burning are consistently relieved by bowel movements, consider a bowel disorder
† Provisional criteria for postprandial EPS: epigastric pain or epigastric burning starts or gets worse after meals ≥50% of the time
Provisional criteria for meal-unrelated EPS: epigastric pain or epigastric burning starts or gets worse after meals <50% of the time
†† Consider a diagnosis of chronic nausea and vomiting syndrome or gastroparesis

B2. NAUSEA AND VOMITING DISORDERS

B2a. Chronic Nausea Vomiting Syndrome (CNVS)

Diagnostic criteria*    Must include all of the following:

1. Bothersome (i.e., severe enough to impact usual activities) nausea occurring at least 2 days per week with or without 1 or more vomiting episodes per week
2. Self-induced vomiting, eating disorders, regurgitation, or rumination are excluded as a cause of vomiting
3. No evidence of structural, systemic, or metabolic diseases that is likely to explain the symptoms in routine investigations
4. Predominant PDS symptoms exclude the diagnosis
5. Predominant nausea and/or persistent vomiting associated with delayed gastric emptying should prompt a diagnosis of gastroparesis

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis

B2b. Cyclic Vomiting Syndrome (CVS)

Diagnostic criteria*    Must include all of the following:

1. Stereotypical episodes of repetitive vomiting regarding onset (acute) and duration (up to 10 days)
2. At least 3 discrete episodes in the prior year and 2 episodes in the past 6 months occurring at least 1 week apart
3. Milder symptoms including nausea and isolated vomiting can be present between cycles

Supportive remark
History or family history of migraine headaches can be present

B3c. Cannabinoid Hyperemesis Syndrome (CHS)

Diagnostic criteria* – Must include all of the following:

1. Stereotypical episodic vomiting resembling cyclic vomiting syndrome (CVS) in terms of onset, duration, and frequency
2. Presentation after prolonged (≥1 year) and excessive (≥4 days per week and/or ≥15 doses per week) cannabis use
3. Relief of vomiting episodes by sustained (at least 6 months or 3 typical emetic cycles) cessation of cannabis use

Supportive remark
May be associated with pathologic bathing behavior (prolonged hot baths or showers)

B3. BELCHING DISORDER

Diagnostic criteria*
Bothersome (i.e., severe enough to impact on usual activities) belching from the esophagus or stomach more than 3 days a week

B3a. Supragastric Belching (from esophagus)

B3b. Gastric Belching (from stomach)

Supportive criteria

1. Supragastric belching is strongly supported by observing frequent, repetitive belching
2. Supragastric belching can be interrupted by maneuvers or distraction
3. Excessive gastric belching has no defining clinical correlate
4. Intraluminal esophageal impedance measurement (with or without concomitant manometry) allows objective differentiation of supragastric from gastric belches.

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

B4. Inability to Belch Syndrome

Diagnostic criteria* 

1. Bothersome inability, or impaired ability to belch at least 3 days per week
2. No evidence of underlying major esophageal disease/dysfunction that explains the symptom (e.g., achalasia, fundoplication, esophagogastric junction outflow obstruction, gastroesophageal reflux disease).

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

Supportive criteria

1. The following associated symptoms can be present:
   1. Chest pain
   2. Gurgling noises in the chest
   3. Bloating
   4. Flatulence
   5. Epigastric pain
2. Esophageal impedance manometry findings are supportive in the diagnosis (air entrapment/oscillations, gas reflux episodes not followed by adequate upper esophageal sphincter (UES) relaxation)

B5. RUMINATION SYNDROME

Diagnostic criteria*    Must include all of the following:

1. Recurrent, seemingly effortless regurgitation of recently ingested food into the mouth, with subsequent oral expulsion or swallowing
2. Regurgitation is not preceded by retching or nausea

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

Supportive criteria

1. The regurgitated material contains recognizable food that might have a pleasant taste.
2. The process tends to cease when the regurgitated material becomes acidic
3. The presence of heartburn may help to differentiate regurgitation in the context of gastroesophageal reflux disease from rumination
4. Combined manometry and impedance monitoring can be used to establish an objective diagnosis of rumination

C. Bowel Disorders

C1. Irritable Bowel Syndrome (IBS)

Diagnostic criteria*
Recurrent, but not continuous, abdominal pain or discomfort on average at least 3 days per month in the last 3 months, associated with two or more of the following criteria:

1. Related to defecation
2. Associated with a change in frequency of stool
3. Associated with a change in form (appearance) of stool

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

Supportive criteria

Abdominal pain/discomfort should not be only related with menses

Rome V Diagnostic criteria for IBS Subtypes

Predominant bowel habits are based on stool form on days with at least one abnormal bowel movement.*

C1a. IBS with predominant constipation (IBS-C): > ¼ (25%) of bowel movements with BSFS stool types 1 or 2 and < ¼ (25%) of bowel movements with Bristol stool types 6 or 7. Alternative for epidemiology or clinical practice: patient reports that abnormal bowel movements are usually constipation (e.g., type 1 or 2 in the picture of BSFS).

C1b. IBS with predominant diarrhea (IBS-D): > ¼ (25%) of bowel movements with BSFS stool types 6 or 7 and < ¼ (25%) of bowel movements with Bristol stool types 1 or 2. Alternative for epidemiology or clinical practice: patient reports that abnormal bowel movements are usually diarrhea (e.g., type 6 or 7 in the picture of BSFS).

C1c. IBS with mixed bowel habits (IBS-M): > ¼ (25%) of bowel movements with BSFS stool types 1 or 2 and > ¼ (25%) of bowel movements with Bristol stool types 6 or 7. Alternative for epidemiology or clinical practice: patient reports that abnormal bowel movements are usually both constipation and diarrhea (more ¼ of all the abnormal bowel movements were constipation and more than ¼ were diarrhea as in the picture of BSFS).

C1d. IBS Unclassified (IBS-U): Patients who meet
diagnostic criteria for IBS but whose bowel habits
cannot be accurately categorized into one of the
three groups above should be categorized as having
IBS-U. Alternative for epidemiology or clinical
practice: patient reports that abnormal stools (both
diarrhea and constipation) are rare.

For clinical trials, subtyping based on at least 2 weeks of daily diary data is recommended, using the “25%-rule.”
* IBS subtypes related to bowel habit abnormalities (IBS-C, IBS-D, and IBS-M) can only be confidently established when the patient is evaluated off medications used to treat bowel habit abnormalities

C2. Chronic Constipation

Diagnostic criteria*

1. Must include two or more of the following:
   1. Straining during more than ¼ (25%) of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
   3. Sensation of incomplete evacuation more than ¼ (25%) of defecations
   4. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
   5. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
   6. Fewer than three spontaneous bowel movements per week
2. Loose stools are rarely present without the use of laxatives
3. Insufficient criteria for irritable bowel syndrome

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

C3. Functional Diarrhea

Diagnostic criteria*

1. Loose or watery stools occurring in more than 25% of bowel movements
2. Hard stools are rarely present without medication that can cause constipation

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

C4. Functional Abdominal Bloating

Diagnostic criteria*     Must include both of the following:

1. Recurrent abdominal bloating and/or visible distension on average at least 1/week; abdominal bloating and/or visible distension predominant over other symptoms.**
2. There are insufficient criteria for the diagnosis of IBS, chronic constipation, functional diarrhea, or postprandial distress syndrome.

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
**Mild pain related to bloating may be present as well as minor bowel movement abnormalities

C5. Unclassified Functional Bowel Disorder

Diagnostic criteria*    Must Include:

Bothersome bowel symptoms not attributable to structural abnormalities and not fully meeting criteria for IBS, chronic constipation, functional diarrhea or functional abdominal bloating disorders.

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

C6. Opioid-Induced Constipation (OIC)

Diagnostic criteria*    Must include:

1. New, or worsening, symptoms of constipation when initiating, changing, or increasing opioid therapy, that must include two or more of the following:
   1. Straining during more than ¼ (25%) of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
   3. Sensation of incomplete evacuation more than ¼ (25%) of defecations
   4. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
   5. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
   6. Fewer than three spontaneous bowel movements per week
2. Loose stools are rarely present without the use of laxatives.

D. Centrally Mediated Disorders of Gastrointestinal Pain

D1. Centrally Mediated Abdominal Pain Syndrome (CAPS)**

Diagnostic criteria*    Must include all of the following:

1. Continuous abdominal pain
2. Nature of relationship of pain with physiological events:
   1. Category A. No association with physiological events or
   2. Category B. Variable association of pain with physiological events†
3. Pain limits some aspect of daily functioning††
4. The pain is not factitious
5. Another GI or non-GI disorder does not explain the continuous abdominal pain

* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months before diagnosis
** CAPS is typically associated with psychosocial comorbidities, but no specific psychosocial profile characterizes a diagnosis of CAPS
† Physiological events may include eating, defecation, menstruation, positioning or other visceral or somatic activities
†† Limitations of daily functioning includes impairments in work, intimacy, social/leisure, family life and caregiving for self or others

D2. Abdominal Migraine

Diagnostic criteria*    Must include all of the following:

1. Paroxysmal, stereotypical episodes of intense abdominal pain lasting 1 hour or more, up to several days
2. The episodes are separated by weeks or months
3. The episodes occur at least 3 times a year and 2 times in the previous 6 months
4. The pain is incapacitating and interferes with everyday activities
5. The pain is associated with two or more of the following:
   1. History of migraine headaches
   2. Family history of migraine headaches
   3. Anorexia, nausea, or vomiting with episodes**
   4. Photophobia
   5. Pallor
   6. Aura or prodrome preceding the full episode
6. After appropriate evaluation, no other medical condition can fully explain the symptoms

* Criteria fulfilled for at least 6 months before diagnosis
** Abdominal migraine is distinguished from CVS because the pain, not the vomiting, is dominant, and the vomiting is not repetitive

D3. Narcotic Bowel Syndrome/Opioid-Induced GI Hyperalgesia

Diagnostic criteria*    Must include all of the following:

1. Chronic or frequently recurring abdominal pain** that is treated with acute high-dose or chronic narcotics
2. The nature and intensity of the pain are not explained by a current or previous GI diagnosis***
3. Two or more of the following:
   1. The pain worsens or incompletely resolves with continued or escalating dosages of narcotics
   2. There is a marked worsening of pain when the narcotic dose wanes and improvement when narcotics are re-instituted (soar and crash)
   3. There is a progression of the frequency, duration and intensity of pain episodes

* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months before diagnosis

** Pain must occur most days

*** A patient may have a structural diagnosis (e.g., inflammatory bowel disease, chronic pancreatitis), but the character or activity of the disease process is not sufficient to explain the pain.

E. Gallbladder and Sphincter of Oddi Disorders

E1. Biliary-Type Abdominal Pain

Diagnostic criteria
Pain located in the epigastrium and/or right upper quadrant and all of the following:

1. Acute onset, lasting at least 20 minutes and up to several hours
2. Episodic, with varying intervals between attacks
3. Severe enough to interrupt daily activities or lead to acute medical evaluation
4. Unrelated to bowel movements and not relieved by acid suppression or positional changes

Supportive characteristics

1. Nausea and vomiting
2. Pain radiates to the back and/or right shoulder blade
3. Pain occurs postprandially
4. Pain awakens patient from sleep

E2. Dysfunctional Gallbladder Disorder (DGBD)

Diagnostic criteria   Must include all of the following:

1. Typical biliary pain
2. Absence of gallstones or other structural pathology

Supportive criteria

1. Normal liver enzymes, conjugated bilirubin, and pancreatic enzymes during the pain episode
2. Persistence of symptoms despite a trial of nonoperative therapy

E3. Biliary Sphincter of Oddi Disorder (SOD)

Diagnostic criteria    Must include all of the following:

1. Typical biliary pain
2. Elevated liver tests and/or biliary dilation
3. Absence of bile duct stones or other structural abnormalities

E4. Pancreatic Sphincter of Oddi Disorder (SOD)

Diagnostic criteria   Must include all of the following:

1. Documented recurrent episodes of acute pancreatitis
2. Other etiologies of pancreatitis excluded*

* Gallstones, alcohol, hypertriglyceridemia, autoimmune, hypercalcemia, medications, pancreatic mass, ampullary lesion, pancreas divisum, anomalous pancreaticobiliary junction, genetic, acute exacerbation of underlying chronic pancreatitis.

F. Anorectal Disorders

F1. Fecal Incontinence (FI)

Diagnostic criteria*   Must include all of the following:

1. Two or more episodes of uncontrolled passage of fecal material*
2. The individual should report at least 1 episode of FI per month on a 4-week stool diary

* Criteria fulfilled for the past 3 months, with symptom onset at least 6 months prior to diagnosis
For clinical purposes, 2 or more episodes of uncontrolled passage of fecal material in the past 12 months

F2. ANORECTAL PAIN DISORDERS

F2a. Levator Ani Syndrome

Diagnostic criteria*   Must include all of the following:

1. Chronic or recurrent anorectal pain
2. Episodes last 30 minutes or longer
3. Tenderness during traction on the puborectalis
4. Exclusion of other causes of anorectal pain such as anal fissure, thrombosed hemorrhoids, malignancy, infectious or inflammatory causes such as inflammatory bowel disease, perianal abscess, fistula, prostatitis, coccygodynia, and gynecological causes of pelvic pain

*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

F2b. Unspecified Functional Anorectal Pain

Diagnostic criteria*

Symptom criteria for chronic levator ani syndrome but no tenderness during posterior traction on the puborectalis muscle

*Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis

F2c. Proctalgia Fugax

Diagnostic criteria*   Must include all of the following:

1. Recurrent episodes of pain localized to the anorectum and unrelated to defecation
2. Episodes last from seconds to minutes
3. No anorectal pain between episodes
4. Exclusion of other causes of anorectal pain such as anal fissure; thrombosed hemorrhoids malignancy; infectious or inflammatory causes such as inflammatory bowel disease, perianal abscess, and fistula; prostatitis; coccygodynia; and major structural disorders of the pelvic floor

* Criteria fulfilled for the past 3 months, with symptom onset at least 6 months prior to diagnosis

F3. Dyssynergic Defecation

Diagnostic criteria*   Must include all of the following:

1. The patient reports one or more symptoms suggestive of difficult evacuation (i.e., excessive straining, use of digital maneuvers to evacuate, sensation of anorectal blockage, and/or feeling of incomplete evacuation) with at least 25% of bowel movements and may satisfy diagnostic criteria for chronic constipation or IBS
2. During attempted defecation, the patient shows features of impaired evacuation, as demonstrated by any one of the following 3 tests**:
   1. Reduced rectoanal pressure gradient or abnormal anorectal evacuation pattern with anorectal manometry
   2. Abnormal balloon expulsion test (BET)
   3. Impaired rectal evacuation with defecography

*Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis

** These abnormalities are identified by comparing the data obtained with age- and gender-appropriate normal values for that particular manometry system. Structural abnormalities such as rectocele, rectal mucosal intussusception, and/or rectal sensory disorders may coexist with dyssynergic defecation.

F4. ANORECTAL SENSORY DYSFUNCTION DISORDERS

F4a. Rectal Hyposensitivity

Diagnostic criteria*   Must include all of the following:

1. Patients fulfill Rome V symptom criteria* for fecal incontinence or dyssynergic defecation.
2. Demonstration of rectal hyposensitivity with rectal balloon distension sensory testing. Hyposensitivity is defined as two or more threshold values (volume/pressure) of rectal sensation (first sensation, desire to defecate, urgency to defecate, or maximum tolerable sensation) that are greater than two standard deviations (SD) of the upper limit of normal range using either a simple balloon (anorectal manometry**) or rectal barostat.
3. No evidence of structural disease on colonoscopy/barium enema or computed tomography scan, and no metabolic abnormalities.

*Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis

** When using anorectal manometry balloon system, such as a latex balloon, rectal sensory thresholds can be affected by rectal compliance, and this factor should be considered when interpreting the results. Patients with chronic constipation and IBS may have rectal sensory dysfunction.

F4b. Rectal Hypersensitivity

Diagnostic criteria*   Must include all of the following:

1. Patients fulfill Rome V symptom criteria* for fecal incontinence or dyssynergic defecation.
2. Demonstration of rectal hypersensitivity with rectal balloon distension sensory testing. Hypersensitivity is defined as one or more threshold values (volume/pressure) of rectal sensation** (desire to defecate, urgency to defecate, maximum tolerable sensation, or pain) that are less than two SD of the lower limit of the normal range using anorectal manometry*** or rectal barostat.
3. No history of rectal excision or evidence of structural disease, including full-thickness rectal prolapse on endoscopy or imaging studies.

*Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis

** Thresholds for first or constant sensation should not be used.

*** When using an anorectal manometry balloon system such as a latex balloon, rectal sensory thresholds can be affected by rectal compliance, and this factor should be considered when interpreting the results

Patients with chronic constipation and IBS may have rectal sensory dysfunction.

G. Pediatric Upper Gastrointestinal Disorders

G1. ESOPHAGEAL DISORDERS

G1a. Reflux Hypersensitivity: Patients <8 years old

Must include all of the following:

1. Intermittent symptoms that
   1. are thought to be gastro-esophageal reflux related;
   2. are suggestive of pain;
   3. are more severe than could be expected based on normal developmental age;
   4. impact on age-expected daily activities and/or quality of life;
   5. occur at least 3 days per week
2. Normal macroscopic esophageal findings on endoscopy and absence of histologic evidence of eosinophilic esophagitis
3. Evidence of triggering of symptoms by acid and/or non-acid reflux events on pH- or pH- impedance monitoring despite normal acid exposure.

* Criteria fulfilled for at least 2 months prior to diagnosis

G1b. Reflux Negative Esophageal Pain Disorder: Patients <8 years old

Must include all of the following:

1. Intermittent symptoms* that
   1. are thought to be gastro-esophageal reflux related;
   2. are suggestive of pain;
   3. are more severe than could be expected based on normal developmental physiology for age;
   4. impact on age-expected daily activities and/or quality of life;
   5. occur at least 3 days per week;
   6. cannot be fully explained by another medical condition after appropriate evaluation.
2. Normal macroscopic esophageal findings on endoscopy and absence of histologic evidence of eosinophilic esophagitis.
3. Normal esophageal acid exposure on pH- or pH-impedance monitoring.
4. No temporal correlation between symptoms and acid or non-acid reflux events on pH- or pH- impedance monitoring.

* Criteria fulfilled for at least 2 months prior to diagnosis

G1c. Esophageal Air Transit

Symptoms that:

1. Are related to the passage of esophageal air
2. Impact on age-expected daily activities and/or quality of life
3. Occur at least 3 days per week
4. After appropriate evaluation, the symptoms cannot be fully explained by other medical condition

Subgroups include:

• G1c.i. Aerophagia syndrome
• G1c.ii. Supragastric belching syndrome

* Criteria fulfilled for at least 2 months prior to diagnosis

G1c.i. Aerophagia Syndrome

Must include the following:

1. Excessive air swallowing that results in bothersome signs or symptoms
2. Abdominal distension due to intraluminal air that increases during the day

Supportive criteria

1. Increased flatus
2. Increased belching and/or gastric venting when a feeding tube is present
3. Intraluminal impedance measurement supporting the diagnosis. Note that absence of aerophagia during the measurement does not exclude the diagnosis
4. Abdominal X-ray showing that intraluminal air is the cause of the distension

G1c.ii. Supragastric Belching Syndrom

Must include all the following:

1. Bursts of repetitive belching originating from the esophagus
2. Does not fulfill criteria for functional dyspepsia, physiological reflux related esophageal pain disorder, reflux-negative esophageal pain disorder

Supportive criteria

1. Do not occur during sleep
2. No air expulsion during distraction or speech
3. Impedance and/or impedance-manometry measurement can support the diagnosis but absence of supragastric belching during the measurement does not exclude the diagnosis

G2. FUNCTIONAL PEDIATRIC FEEDING DISORDERS

Altered feeding patterns that (a) interfere with functioning; (b) occur for at least 3 times per week; and (c) cannot be attributed to an underlying medical or skill-based diagnosis that has been effectively evaluated and managed.

The diagnosis should have at least one of the following components:

1. Evidence of nutritional compromise (micronutrient deficiency, macronutrient deficiency)
2. Use of supplemental enteral or parenteral nutrition
3. Active or passive avoidance behavior(s)
4. Use of a restricted/selective diet or a diet that is not developmentally appropriate to treat symptoms
5. Lack of developmentally expected self-feeding
6. Excessive use of routine feeding strategies (e.g., chewing, liquid wash down, pacing) to complete a meal

* Criteria fulfilled for at least 1 month prior to diagnosis

G2a. Hypersensitive Dysphagia

A feeding disorder characterized by perception of liquids and/or solid foods passing abnormally through the oropharynx or esophagus that is associated with all of the following characteristics:

1. No evidence of pharyngeal or esophageal mucosal or structural abnormalities
2. Absence of major esophageal motor disorders
3. No evidence of bolus transit abnormalities

G2b. Anticipatory Restrictive Feeding

A functional feeding disorder driven by the anticipation of aversive experiences while eating and is associated with one or more of the following

1. Significant weight loss (or failure to achieve expected weight gain or faltering growth in children)
2. Significant nutritional deficiency
3. Dependence on enteral feeding or oral nutritional supplements
4. Marked interference with other psychosocial functioning

G2c. Hunger Dysregulation Disorders

A feeding disorder that is characterized by either:

• G2c.i. Reduced hunger drive. The patient will not voluntarily eat or drink calorically appropriate foods after periods of age-appropriate fasting AND the patient requires prompting and/or scheduling of meals in order to insure adequate intake.
• G2c.ii. Excessive hunger drive. The patient has excessive hunger manifested by inability to stop eating even after finishing a meal and excessive eating between meals even after completing a full meal

G2d. Medically Triggered Functional Feeding Disorder

A feeding disorder that:

• Developed in the context of a medical condition but the feeding dysfunction persisted after the medical disorder has resolved or is adequately treated and cannot be attributed to the underlying medical condition
• Manifests as a regression or lack of progression of feeding patterns or skills that previously achieved and cannot be attributed to the medical condition

G3. GASTRODUODENAL DISORDERS

G3a. Rumination Syndrome

Must include all of the following symptoms for minimum 2 months, starting after 3 months of age:

1. Repeated, seemingly effortless regurgitation of gastric contents that is:
   1. Re-swallowed and/or re-chewed and/or expelled during or immediately after a meal or ingestion of fluids
   2. Does not occur during sleep
2. Does not respond to standard management for gastroesophageal reflux disease or infant regurgitation.

After appropriate evaluation, the symptoms cannot be fully explained by another medical condition. An eating disorder must be ruled out.

Supportive criteria

1. The repeated regurgitation of gastric contents might occur during or after physical or psychological stress
2. High-resolution esophageal impedance manometry (HRIM) may help confirm the diagnosis in cases of unusual symptomatology or family skepticism. HRIM allows for prompt identification of the rumination episodes, with the sensitivity maximized by an extended recording after a test meal

* Criteria fulfilled for at least 1 month prior to diagnosis

G3b. Cyclic Vomiting Syndrome

Diagnostic criteria   Must include all of the following:

1. Stereotypical episodes of acute onset, repetitive vomiting multiple times per hour
2. ≥4 discrete episodes in the prior 12 months, lasting 2 hours to 7 days
3. Episodes at least 1 week apart
4. Return to baseline health between episodes
5. After appropriate evaluation, the symptoms cannot be fully explained by other medical conditions

Supportive remarks:

1. History or family history of migraine headaches
2. Episodes associated with listlessness, diaphoresis, photophobia, unrelenting nausea, abdominal pain, and/or incessant retching after emptying stomach
3. Less acute or intermittent symptoms such as abdominal pain and nausea can be present between episodes

G3b.i. Cannabinoid Hyperemesis Syndrome

Diagnostic criteria   Must include all of the following:

1. Stereotypical episodes of vomiting resembling cyclic vomiting syndrome (CVS) in terms of onset, duration and frequency
2. Presentation after prolonged (e.g., 1–2 years), excessive (e.g. near daily) cannabis use
3. Resolution of vomiting episodes by sustained (at least 6 months) cessation of cannabis use

Supportive remarks:

1. May be associated with pathologic bathing behavior (prolonged hot baths or showers)
2. Diagnosis strengthened by positive urine -9-tetrahydrocannabinol (THC) test

G3c. Chronic Nausea Syndrome*

Must include all of the following:

1. Bothersome nausea as the predominant symptom, occurring at least twice per week
2. Not associated with vomiting
3. Does not meet criteria for functional dyspepsia or other DGBI
4. After appropriate evaluation, the nausea cannot be fully explained by another medical condition

* Criteria fulfilled for at least 2 months before diagnosis

G3d. Functional Dyspepsia

Must include one or more of the following bothersome symptoms:

1. Postprandial fullness
2. Early satiation
3. Epigastric pain or burning

After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.

* Criteria fulfilled for at least 2 months before diagnosis

Two subtypes:

• G3d.i. Postprandial distress syndrome
• G3d.ii. Epigastric pain syndrome

G3d.i. Postprandial Distress Syndrome

Must include one or more of the following bothersome symptoms at least 3 days per week

1. Bothersome postprandial **fullness that occurs with completion of a developmentally and culturally appropriate meal
2. Early satiation that prevents finishing a developmentally and culturally appropriate meal

Supportive features include upper abdominal bloating, postprandial nausea, discomfort or excessive belching.

** Postprandial means that’s symptoms are triggered within 2 hours after meal intake

G3d.ii. Epigastric Pain Syndrome

Must include one or more of the following bothersome symptoms (interferes with function or quality of life) at least 1 day per week:

1. Pain or burning localized to the epigastrium.
2. The pain is not present in any other abdominal or chest region
3. Symptoms can be induced or worsened post-prandially or can occur independently of meals but PDS criteria are not fulfilled
4. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition including functional abdominal pain or IBS

H. Pediatric Lower Gastrointestinal and Biliary Disorders

H1. ABDOMINAL PAIN DISORDERS

H1a. Irritable Bowel Syndrome

Must include all of the following:

1. Intermittent abdominal pain on average of at least 4 days per month** associated with one or more of the following:
   1. Related to defecation (i.e., worsening or amelioration of)
   2. A change in frequency of stool
   3. A change in form (appearance) of stool
2. Abdominal pain is the predominant symptom
3. After appropriate evaluation, the symptoms cannot be fully explained by other medical conditions

*Criteria fulfilled for at least 2 months before diagnosis

** Can not occur only during menstrual periods

H1b. Abdominal Pain Syndrome—Not Otherwise Specified

Must be fulfilled an average of at least 4 days per month and includee all of following:

1. Intermittent abdominal pain that does not occur solely during meals, defecation or menses.
2. Insufficient criteria for irritable bowel syndrome, functional dyspepsia, abdominal migraine or biliary pain syndrome.
3. After appropriate evaluation, the abdominal pain cannot be fully explained by another medical condition.

*Criteria fulfilled for at least 2 months before diagnosis

H1c. Biliary Pain Syndrome

Main criteria (need to meet all)

1. Pain in the right upper quadrant with or without epigastric pain occurring at least an average of 4 days per month, with all the following characteristics:
   1. Acute onset, lasting at least 30 minutes and up to several hours
   2. Episodic, with varying intervals between attacks
   3. Severe enough to lead to acute medical evaluation
2. Symptoms do not meet criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine
3. Absence of gallstones or other structural gallbladder or biliary tract pathology
4. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition

Supportive criteria

1. Normal liver enzymes, conjugated bilirubin, and pancreatic enzymes during or within a few days of the episodes
2. Nausea and vomiting
3. Pain radiates to the back and/or right shoulder blade
4. Pain occurs postprandially
5. Pain awakens the patient from sleep

*Criteria fulfilled for at least 2 months before diagnosis

H1d. Abdominal Migraine

Diagnostic criteria*    Must include all of the following occurring at least twice:

1. Paroxysmal episodes of intense and acute periumbilical, midline, or diffuse abdominal pain lasting 1 hour or more. Pain should be the most severe and distressing symptom.
2. Episodes are separated by at least 1 week
3. The pain is incapacitating and interferes with normal activities
4. Stereotypical pattern and symptoms in the individual patient
5. The pain is associated with two or more of the following:
   1. Anorexia
   2. Nausea
   3. Vomiting
   4. Headache
   5. Photophobia
   6. Pallor
6. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition, including cyclic vomiting syndrome.

*Criteria fulfilled for at least 2 months before diagnosis

H1e. Centrally Mediated Abdominal Pain Syndrome**

Must include all of the following:

1. Continuous abdominal pain
2. Pain limits some aspects of daily functioning***
3. After appropriate evaluation, the symptoms cannot be fully explained by other medical conditions

*Criteria fulfilled for at least 2 months before diagnosis

** CAPS is typically associated with psychosocial comorbidity, but there is no specific profile that can be used for diagnosis

*** Daily activities include impairment in school, social/leisure, family life, and sports

H2. DEFECATION AND ANORECTAL DISORDERS

H2a. Functional Constipation

1. Must include at least two of the following occurring in the past month
   1. On average, 2 or fewer defecations per week
   2. On average, at least 1 episode of fecal incontinence per week**
   3. History of retentive posturing, straining, or inappropriate stool retention
   4. History of painful or hard*** bowel movements
   5. Presence of a large fecal mass in the rectum
   6. History of large diameter stools
2. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
3. Does not fulfill criteria for irritable bowel syndrome

* Criteria fulfilled for at least 1 month before diagnosis

** This criterion only applies to children who have been toilet-trained

*** Bristol Stool Scale type 1 or 2, or Brussels Infants and Toddlers Stool Scale type 1, 2, or 3 for infants.

H2b. Nonretentive Fecal Incontinence

Diagnostic criteria*   Must include all of the following in a child who has been toilet trained:

1. Defecation into places inappropriate to the sociocultural context
2. No evidence of fecal retention
3. The incontinence should not be purposeful
4. After appropriate evaluation, the fecal incontinence cannot be explained by another medical condition.

*Criteria fulfilled for at least 1 month before diagnosis

H2c. Infant Dyschezia

Diagnostic criteria    Must include both of the following in an infant younger than 9 months:

1. Straining for at least 10 minutes and visible effort to defecate before successful or unsuccessful passage of soft stools. It is often accompanied by screaming, crying, or extreme reddening of the face.
2. After appropriate evaluation, the discomfort cannot be fully explained by another medical condition.

H2d. Proctalgia Fugax

Must include all of the following:

1. Intermittent pain localized to the anorectum and unrelated to defecation
2. Pain generally lasts from seconds to minutes
3. There is no anorectal pain between episodes
4. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition

*Criteria fulfilled for at least 2 months before diagnosis

H2e. Functional Diarrhea

Diagnostic criteria     Must include all of the following:

1. Passage of an average of four or more painless bowel movements daily in children younger than 4 years old or more than two bowel movements daily in children ≥4 years old, with at least 25% of stools being unformed**
2. Onset between 6 months and 18 years of age
3. Does not meet criteria for functional constipation, diarrhea predominant irritable bowel syndrome, and nonretentive fecal incontinence
4. After appropriate evaluation, the diarrhea cannot be fully explained by another medical condition

*Criteria fulfilled for at least 2 months before diagnosis

** Bristol Stool Scale or Brussels Infants and Toddlers Stool Scale type 6 or 7 in infants/children with diaper

H3. DISCOMFORT DISORDERS

H3a. Functional Abdominal Bloating

Must include all the following:

1. Intermittent bloating and/or distension occurring on average at least 4 days per month over at least 2 months; abdominal bloating and/or distension predominate over other symptoms**
2. There are insufficient criteria for a diagnosis of irritable bowel syndrome, functional constipation, functional diarrhea, aerophagia, or postprandial distress syndrome
3. After appropriate evaluation, the bloating cannot be fully explained by another medical condition

*Criteria fulfilled for at least 2 months before diagnosis

** Mild pain related to bloating may be present as well as minor bowel movement abnormalities

H3b. Infant Distress Syndrome

For clinical purposes, must include all the following:

1. An infant who is younger than 5 months of age when the symptoms start
2. Recurrent and prolonged periods of infant crying and fussing* reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers
3. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition