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Irritable Bowel Syndrome and Low FODMAP Diet (FructIBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188680
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Low FODMAPS diet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?
Study Start Date : January 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arm Intervention/treatment
Active Comparator: 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
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

Sham Comparator: negative breath testing for fructose
patients with negative breath test have a low FODMAPS diet
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




Primary Outcome Measures :
  1. Fructose expiration rate (ppm) [ Time Frame: Day 15 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188680


Contacts
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Contact: Anne-Marie LEROI, Professor 02 32 88 80 39 ext +33 anne-marie.leroi@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive Recruiting
Rouen, Haute Normandie, France, 76031
Contact: Anne-Marie LEROI, Professor    02 32 88 80 39 ext +33    anne-marie.leroi@chu-rouen.fr   
Principal Investigator: Anne-Marie LEROI, Professor         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Anne-Marie LEROI, Professor University Hospital, Rouen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02188680    
Other Study ID Numbers: 2013/011/HP
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Rouen:
fructose test
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases