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Irritable Bowel Syndrome and Low FODMAP Diet (FructIBS)

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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

Tracking Information
First Submitted Date  ICMJE August 26, 2013
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irritable Bowel Syndrome and Low FODMAP Diet
Official Title  ICMJE Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Low FODMAPS diet
  • Sham Comparator: negative breath testing for fructose
    patients with negative breath test have a low FODMAPS diet
    Intervention: Other: Low FODMAPS diet
Publications * Melchior C, Desprez C, Houivet E, Debeir LA, Bril L, Maccarone M, Grout E, Ducrotté 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188680
Other Study ID Numbers  ICMJE 2013/011/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Marie LEROI, Professor University Hospital, Rouen
PRS Account University Hospital, Rouen
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP