CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Diet low in FODMAPs +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03423069
NCT03423069N/ACompleted

Effects of a Diet Low in Fructose, Oligosaccharides, Disaccharides, Monosaccharides, Alcohols and Polyols in Patients With Irritable Bowel Syndrome Diarrheal Variant Respect to Dietary Advice: Randomized, Single Blind Clinical Trial.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis·interventional·Posted Feb 6, 2018·Updated Mar 22, 2022

In Brief

A clinical study evaluating Diet low in FODMAPs and Specific dietary advice for IBS for Irritable Bowel Syndrome. Completed, enrolled 62 participants across 1 site.

Detailed Summary

A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so far few randomized trials have reported data in favor of the effective therapeutic superiority of a low-FODMAPs diet compared to specific IBS dietary advice. On this basis, the present study is aimed, in a multidisciplinary perspective, at investigating possible changes in the symptom profile and intestinal permeability, GI peptides concentrations, metabolic and lipidomic profiles induced by these different diets in patients with IBS diarrheal variant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 6, 2018
Enrollment StartFeb 5, 2018
Primary CompletionJul 30, 2019
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.4 years ago

Interventions

Diet low in FODMAPsdietary

A strict restriction of all high FODMAP foods for the time of observation. All these foods will be identified by appropriate nutritional visits and alternatives will be suggested to ensure the diet is nutritionally adequate.

Specific dietary advice for IBSdietary

Dietary recommendations such as limitation of alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoidance of chewing gums and sweeteners containing polyols; small and frequent meals; avoidance of stressful conditions and eating slowly.