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Irritable Bowel Syndrome and Low FODMAP Diet (FructIBS)

U

University Hospital, Rouen

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Other: Low FODMAPS diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02188680
2013/011/HP

Details and patient eligibility

About

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.

Full 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

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Low FODMAPS diet and positive breath testing for fructose
Active Comparator group
Description:
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
Treatment:
Other: Low FODMAPS diet
negative breath testing for fructose
Sham Comparator group
Description:
patients with negative breath test have a low FODMAPS diet
Treatment:
Other: Low FODMAPS diet

Trial contacts and locations

1

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Central trial contact

Anne-Marie LEROI, Professor; Julien BLOT

Data sourced from clinicaltrials.gov

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