Intracolonic FODMAP Infusion in Healthy Volunteers
NCT Number: NCT06488534
Acronym: ICOF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome
Interventions: DIETARY_SUPPLEMENT: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)
Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: University of Auckland, New Zealand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2023-06-26
Completion Date: 2024-09-30
Locations: KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

Summary:
Irritable bowel syndrome (IBS) is one of the most common chronic diseases of the gut-brain axis. The underlying pathophysiology is multifactorial, poorly understood and differs between the subtypes: constipation-dominant IBS, diarrhea-dominant IBS, mixed IBS, and unspecified IBS. Although it is considered a motility disorder, no uniform motility patterns have been found in IBS patients and no link has yet been found between the motility patterns and the typical complaints such as nausea, fullness, cramps and flatulence. These symptoms are often diagnosed after a meal and research has shown that especially fermentable oligo, di, monosaccharides and polyols (FODMAPs) give rise to symptoms. Many studies have tested the effect of these FODMAPs after oral administration, but little is known about their direct effect on the colon. In this double-blind cross-over study, 15 healthy volunteers are subjected to 3 colonoscopies in which a catheter is placed to measure the pressures in the large intestine and to administer the dissolved FODMAPs. Volunteers will follow a diet low in fiber and FODMAPs 3 days before each study visit. In addition, they will have to record their daily bowel movements during the week of their study visit and fill in 2 short questionnaires on the day of the study visit regarding their gastrointestinal complaints. There will be at least 2 weeks between the 3 study visits to avoid any overlap between the FODMAPs.

Primary Outcome Measures: colonic motility, evaluation of (high amplitude) propagating contractions, simultaneous pressure waves at 3 predefined timepoints: upon awakening, after FODMAP infusion and postprandially, through study completion, an average of 1 year
Secondary Outcome Measures: abdominal symptoms, symptoms will be registered every 15minutes during the evaluation of the colonic motility, through study completion, an average of 1 year|stool form based on the bristol stool chart, stool form differences will be evaluated during the week of the investigation (3 days before the study visit, on the day of investigation, and 3 days after the study visit), through study completion, an average of 1 year|IBS-SSS and IBS-Qol, IBS symptom severity and influence of quality of life will be assessed at each investigation and compared between the 3 study arms., through study completion, an average of 1 year|microbiome, a stool sample will be taken before the first study visit to evaluate the microbial composition, through study completion, an average of 1 year|colonic motor patterns by means of high resolution electrocolonography, simultaneous evaluation of colonic motor patterns with high-resolution colonic manometry and high-resolution electrocolonography, through study completion, an average of 1 year|validation of the high-resolution electrocolonography, evaluation of the high-resolution electronography als a non-invasive tool for the measurement of colonic motility, through study completion, an average of 1 year