Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
November 27, 2015 updated by: Hospital Universitari Vall d'Hebron Research Institute
Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08035
- Vall d'Hebron Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Birth control pill
- Intra-uterine device (IUD)
- Double barrier methods (such as condoms and spermicide)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bimuno Galacto-oligosaccharide
Dietary intervention
|
Prebiotic versus low-FODMAPs diet
|
|
Placebo Comparator: Low- FODMAPs diet
Dietary intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut microbiota composition
Time Frame: 28 days
|
Effect of treatment on the response of microbiota to 3-day challenge diet
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiota activity (intestinal gas production)
Time Frame: 28 days
|
Intestinal gas evacuation on standardized diet
|
28 days
|
|
Digestive symptoms
Time Frame: 28 days
|
Digestive sensations measured by scales
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fernando Azpiroz, MD, Vall d'Hebron Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 5, 2014
First Submitted That Met QC Criteria
August 5, 2014
First Posted (Estimate)
August 6, 2014
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 27, 2015
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)296/2013/A-4/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.