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NCT02188680 Clinical Trial

Irritable Bowel Syndrome and Low FODMAP Diet

Irritable Bowel Syndrome Clinical Trial

— FructIBS  

Official title:
Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02188680
Other study ID # 2013/011/HP
Secondary ID
Status Recruiting
Phase N/A
First received August 26, 2013
Last updated June 13, 2017
Start date January 2014
Est. completion date January 2018

Study information
Verified date June 2017
Source University Hospital, Rouen
Contact Anne-Marie LEROI, Professor
Phone 02 32 88 80 39
Email anne-marie.leroi@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 112
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Low FODMAPS diet
FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose

Locations
Country Name City State
France Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive Rouen Haute Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fructose expiration rate (ppm) 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. Day 15
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