2014 Research Award Recipient
Principle Investigator: Stacy Menees, MD, MS
Assistant Professor
Division of Gastroenterology
University of Michigan
Dr. Stacy Menees is a Clinical Lecturer, Division of Gastroenterology, at the University of Michigan School Of Medicine at Ann Arbor, and a staff physician, Division of Gastroenterology, at the Ann Arbor Veterans Administrations Health System. She received her M.D. from University of Wisconsin School of Medicine in Madison and also completed a Master of Science degree in Clinical Research Design and Statistical Analysis from the University of Michigan School Of Public Health in Ann Arbor. Her primary clinical interest is colorectal cancer screening and her research was awarded the ASGE distinction for best “gender-based research presentation” at DDW 2004. Additional clinical interests include endoscopic ultrasound, fecal incontinence, constipation and women’s health.
Title: A randomized controlled trial to assess the efficacy of the low FODMAP diet in patients with fecal incontinence and loose stools.
Background: Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed.
Aims: 1. Compare the treatment response with a low FODMAP vs. usual care (high fiber diet) based on number of episodes in patients with FI. 2. Compare the efficacy of a low FODMAP diet vs. standard dietary advice in patients with FI on pre-specified clinical and quality of life endpoints.
Methods: This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 2 episodes of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to high fiber vs. low FODMAP diet for 4 weeks. A total of 33 patients will be recruited for each arm. The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of episodes by 50% or more compared to baseline. Key secondary outcomes including stool consistency, stool frequency, FI-QOL scores, FISI scores will be compared between groups before and after the dietary intervention.
This is a novel proposal as there is no data on low FODMAPs as treatment for fecal incontinence with soft or loose stool. This research will be utilized as pilot data for a RO1 or VAHSR Merit Award. For these awards, I will implement the research findings from Aims 1 and 2. Aims 1 and 2 will inform sample size calculations.