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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210572
• Other study ID #: PR(AG)296/2013/A-4/2014
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: November 27, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Bimuno Galacto-oligosaccharide 1.37 g/d
Prebiotic versus low-FODMAPs diet
• Low- FODMAPs diet

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota composition	Effect of treatment on the response of microbiota to 3-day challenge diet	28 days	No
Secondary	Microbiota activity (intestinal gas production)	Intestinal gas evacuation on standardized diet	28 days	No
Secondary	Digestive symptoms	Digestive sensations measured by scales	28 days	No