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Bloating Survey: Coordinated Study With Rome Foundation Research Institute and Danone Nutricia Research

Danone Nutricia Research and the Rome Foundation Research Institute (RFRI) have joined forces to launch an unprecedented survey aiming to uncover the frequency and severity of gastrointestinal symptoms (ex: bloating) their potential determinants and their impact on quality of life in the general adult population of three countries: The United States, Mexico and United Kingdom. The study will combine in the same large-scale assessment of a multi-national population sample the use of the newly validated Intestinal Gas Questionnaire (IGQ), diagnostic evaluation of functional bloating/distention with the Rome IV diagnostic criteria and lifestyle parameters. A sub-study will be carried out in each country for comprehensive assessment of dietary patterns and nutritional intake. The Researcher hope to unlock the link between diet, lifestyle and gut discomfort, paving the way forward in personal nutrition.


ROBOT- Rome Foundation BioMarker & Phenotyping Project

The aim of this ROme foundation BiOmarker and phenotyping projecT (ROBOT) is to develop a state-of-the-art biobank and database of patients with DGBI supported by an international network of top international researcher sites. Patients in the database will be thoroughly characterized with regard to their clinical phenotype and associated demographic, medical history, psychosocial and lifestyle factors, their fecal, blood and urine samples will be collected and stored in a standardized fashion, and in select sites also biopsies from the upper and/or lower GI tract depending on the predominant symptomatology. This biosample and data collection will be uniform across all sites and will enable evaluation of different biomarkers in large groups of very well-characterized individuals in different parts of the world and to assess their ability to be used as diagnostic and /or predictive tools. A centralized electronic database will enable development of profiles of available clinical phenotypes and biosamples at any time to assess the feasibility of new studies.


Domino Trial

The DOMINO trial (Diet or Medication in Irritable bowel syndrome) is a randomized trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care. This trial is funded by Belgian Government Money, is pragmatic and aims at optimizing primary care. It uses questionnaires that were developed for the Rome IV Global Epidemiology study in Belgium and also serves as an opportunity to collect biobank material from primary care IBS patients. Patients are randomized to treatment with OB 60 mg t.i.d., the traditional first-line medical therapy, or by a FODMAP lowering diet, provided via a smartphone application. Before and after 8 weeks of treatment, patients completed questionnaires evaluating demographics, stool types, Rome IV criteria, IBS-Symptom Severity (IBS-SSS), anxiety (GAD), depression (PHQ9) and somatization (PHQ15).As of December 4th, 2019 a total of 466 of the targeted 470 patients were enrolled and 95% of the subjects provided biobanking samples for genetics, serum and stool analysis. Patients with an improvement of at least 50 points on IBS-SSS were considered as a responder. The following paragraphs summarize abstracts regarding this study, which were submitted to FNM 2020 and to DDW 2020. At baseline, 70 % of these primary care-diagnosed IBS patients fulfill the Rome 4 criteria. (74% female, mean age 42±0.9 years, and mean BMI of 24±0.3). The following IBS-SSS distribution was found: 4, 16, 41, 39 % for normal, mild, moderate, and severe IBS-SSS respectively. Patients were characterized according to the stool pattern: diarrhea (27%), constipation (23%), mixed stool type (38%) and normal (12%). Respectively 59% and 70% of patients treated with OB and diet were IBS-SSS responders. In the OB group, responders had significantly higher somatization scores compared to non-responders (10.5±0.5 vs 9.0±0.4, p=0.01), but both groups had comparable demographic and other clinical characteristics. Responders to the diet were significantly younger than non-responders (mean age 39±1 vs 44.6±2 (p=0.03). Diet response was not determined by the stool pattern subtype, but Rome+ patients were significantly more likely to respond to the diet compared to Rome-(p=0.002). The primary endpoint analysis is anticipated in early February 2020.

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