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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Dietary Supplement: Bimuno Galacto-oligosaccharide 1.37 g/d; Dietary Supplement: Low- FODMAPs diet

• Registration Number: NCT02210572
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimuno Galacto-oligosaccharide	Bimuno Galacto-oligosaccharide 1.37 g/d	Dietary intervention
Low- FODMAPs diet	Low- FODMAPs diet	Dietary intervention

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition	28 days	Effect of treatment on the response of microbiota to 3-day challenge diet

Secondary Outcome Measures

Name	Time	Method
Digestive symptoms	28 days	Digestive sensations measured by scales
Microbiota activity (intestinal gas production)	28 days	Intestinal gas evacuation on standardized diet

Trial Locations

Locations (1)

Vall d'Hebron Research Institute; 🇪🇸 Barcelona, Spain