Status:
COMPLETED
Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18-80 years
Phase:
NA
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02210572
Start Date
August 1 2014
End Date
July 1 2015
Last Update
November 30 2015
Active Locations (1)
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1
Vall d'Hebron Research Institute
Barcelona, Barcelona, Spain, 08035