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Irritable Bowel Syndrome and Low FODMAP Diet (FructIBS)

Primary Purpose

Irritable Bowel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Low FODMAPS diet

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring fructose test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Service de Physiologie Digestive, Urinaire, Respiratoire et SportiveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low FODMAPS diet and positive breath testing for fructose

negative breath testing for fructose

Arm 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

patients with negative breath test have a low FODMAPS diet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02188680

First Posted

August 26, 2013

Last Updated

June 13, 2017

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT02188680

Brief Title

Irritable Bowel Syndrome and Low FODMAP Diet

Acronym

FructIBS

Official Title

Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

fructose test

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low FODMAPS diet and positive breath testing for fructose

Arm Type

Active Comparator

Arm Description

Arm Title

negative breath testing for fructose

Arm Type

Sham Comparator

Arm Description

patients with negative breath test have a low FODMAPS diet

Intervention Type

Other

Intervention Name(s)

Low FODMAPS diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Fructose expiration rate (ppm)

Description

Time Frame

Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Marie LEROI, Professor

Phone

02 32 88 80 39

Ext

+33

anne-marie.leroi@chu-rouen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Julien BLOT

julien.blot@chu-rouen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne-Marie LEROI, Professor

Organizational Affiliation

University Hospital, Rouen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive

City

Rouen

State/Province

Haute Normandie

ZIP/Postal Code

76031

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne-Marie LEROI, Professor

Phone

02 32 88 80 39

Ext

+33

anne-marie.leroi@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Anne-Marie LEROI, Professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

31113646

Citation

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.

Results Reference

derived

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Irritable Bowel Syndrome and Low FODMAP Diet

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