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

Vall d'Hebron University Hospital (HUVH)

Status

Completed

Conditions

Functional Gastrointestinal Disorders

Treatments

Dietary Supplement: Low- FODMAPs diet

Dietary Supplement: Bimuno Galacto-oligosaccharide 1.37 g/d

Study type

Interventional

Funder types

Other

Identifiers

NCT02210572

PR(AG)296/2013/A-4/2014

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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