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Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms

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ClinicalTrials.gov Identifier: NCT02210572
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
It has been shown that patients complaining of gas-related symptoms significantly improve on a diet low in fermentable residues. However, other studies suggest that some non-absorbable, fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce beneficial effects to the host, including improvement of abdominal symptoms. The aim of the study is to compare the effects of a diet low in fermentable residues versus a diet suplemented with prebiotics on intestinal microbiota composition, microbiota activity (intestinal gas production) and digestive symptoms.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Dietary Supplement: Bimuno Galacto-oligosaccharide 1.37 g/d Dietary Supplement: Low- FODMAPs diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Bimuno Galacto-oligosaccharide
Dietary intervention
Dietary Supplement: Bimuno Galacto-oligosaccharide 1.37 g/d
Prebiotic versus low-FODMAPs diet

Placebo Comparator: Low- FODMAPs diet
Dietary intervention
Dietary Supplement: Low- FODMAPs diet



Primary Outcome Measures :
  1. Gut microbiota composition [ Time Frame: 28 days ]
    Effect of treatment on the response of microbiota to 3-day challenge diet


Secondary Outcome Measures :
  1. Microbiota activity (intestinal gas production) [ Time Frame: 28 days ]
    Intestinal gas evacuation on standardized diet

  2. Digestive symptoms [ Time Frame: 28 days ]
    Digestive sensations measured by scales



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Functional digestive disorder with flatulence
  • Women and men between the ages of 18 and 80 years (bounds included at the inclusion visit).
  • Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2 (bounds included)).
  • Women of childbearing potential should be using or complying with one of the medically approved methods of contraception such as, but not exclusively, one of the following:

    1. Birth control pill
    2. Intra-uterine device (IUD)
    3. Double barrier methods (such as condoms and spermicide)
    4. Abstinence
  • Willing to follow strict dietary instructions for the duration of the study
  • Able to communicate well with the investigator and to comply with the requirements for the study.

Exclusion Criteria:

  • Significant illness other than functional bowel disorders
  • Disease/disorders which can interfere with the collection of the gas (hemorrhoids,..etc)
  • Antecedents of digestive surgery, excluding appendicectomy
  • Intake of antibiotics in the month (within 30 days) preceding the inclusion visit.
  • Current use of any medications with potential central nervous system effects as judged by the investigator (including but not limited to antidepressants, anxiolytics, opiate pain medications)
  • Taking drugs that might modify gastrointestinal function
  • Change of dietary habits within the preceding 4 weeks (for instance start of a diet high in fiber) or planned change (For example to start a diet) during the period of the study

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): NCT02210572


Locations
Spain
Vall d'Hebron Research Institute
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Fernando Azpiroz, MD Vall d'Hebron Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02210572     History of Changes
Other Study ID Numbers: PR(AG)296/2013/A-4/2014
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: August 2014

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Intestinal microbiota
Intestinal gas
Dietary intervention
Low-FODMAPs diet
Prebiotics

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases