Irritable Bowel Syndrome and Low FODMAP Diet

NCT02188680 | Completed

• 1 other identifier: 2013/011/HP
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

fructose test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low FODMAPS diet and positive breath testing for fructose

ACTIVE COMPARATOR

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

Other: Low FODMAPS diet

negative breath testing for fructose

SHAM COMPARATOR

patients with negative breath test have a low FODMAPS diet

Other: Low FODMAPS diet

Interventions

Low FODMAPS diet 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

Low FODMAPS diet and positive breath testing for fructose; negative breath testing for fructose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive

Rouen, Haute Normandie, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 31113646 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anne-Marie LEROI, Professor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: July 11, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 6, 2026

Record last verified: 2023-04

Locations

FR (1)