Irritable Bowel Syndrome and Low FODMAP Diet

NCT ID: NCT02188680

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-01-31

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

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low FODMAPS diet and positive breath testing for fructose

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

Group Type: ACTIVE_COMPARATOR

Low FODMAPS diet

Intervention Type: OTHER

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

negative breath testing for fructose

patients with negative breath test have a low FODMAPS diet

Group Type: SHAM_COMPARATOR

Low FODMAPS diet

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Marie LEROI, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive

Rouen, Haute Normandie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne-Marie LEROI, Professor

Role: CONTACT

anne-marie.leroi@chu-rouen.fr

02 32 88 80 39 ext. +33

Julien BLOT

Role: CONTACT

julien.blot@chu-rouen.fr

Facility Contacts

Anne-Marie LEROI, Professor

Role: primary

anne-marie.leroi@chu-rouen.fr

02 32 88 80 39 ext. +33

References

Melchior C, Desprez C, Houivet E, Debeir LA, Bril L, Maccarone M, Grout E, Ducrotte P, Gourcerol G, Leroi AM. Is abnormal 25 g fructose breath test a predictor of symptomatic response to a low fructose diet in irritable bowel syndrome? Clin Nutr. 2020 Apr;39(4):1155-1160. doi: 10.1016/j.clnu.2019.04.031. Epub 2019 May 8.

Reference Type: DERIVED

PMID: 31113646 (View on PubMed)

Other Identifiers

2013/011/HP

Identifier Type: -

Identifier Source: org_study_id