Irritable Bowel Syndrome and Low FODMAP Diet

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Low FODMAPS diet

• Registration Number: NCT02188680
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

Detailed Description

The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to correlate the results with the respiratory test

Study Timeline

• Study First Submitted: 2013-08-26
• Study Start: 2014-01
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• older than 18, patients with IBS, patients with no organic disorders, patients informed and agreed to participate

Exclusion Criteria

• patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients with small intestinal bacterial overgrowth, pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low FODMAPS diet and positive breath testing for fructose	Low FODMAPS diet	Patients with breath testing positive have a low FODMAPS diet. The test will be considered as positive if we observe an increase of more than 20 ppm of H2 and/or CH4 on a sample with regard to the basal concentration
negative breath testing for fructose	Low FODMAPS diet	patients with negative breath test have a low FODMAPS diet

Primary Outcome Measures

Name	Time	Method
Fructose expiration rate (ppm)	Day 15	Estimate the value of the fructose test to predict the efficiency of a diet excluding the fructose and its by-products on the digestive symptoms of the patients having a Syndrome of the irritable bowel.

Trial Locations

Locations (1)

Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive; 🇫🇷 Rouen, Haute Normandie, France