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

Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria have been shown to improve this type of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics.

Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Bimuno Galacto-oligo-saccharide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

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:

-

Exclusion Criteria:

• gastrointestinal symptoms
• recent (3 months) antibiotic intake
• recent (3 months) change of diet
• recent (3 months) gastroenteritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects; Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks	Dietary supplement: Bimuno Galacto-oligo-saccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of daily anal gas evacuations	Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)

Secondary Outcome Measures

Outcome Measure	Time Frame
Volume of anal gas evacuation	Change from beginning of treatment (day 3) to end of treatment (day 21)

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Fernando Azpiroz, MD, Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• Mego M, Manichanh C, Accarino A, Campos D, Pozuelo M, Varela E, Vulevic J, Tzortzis G, Gibson G, Guarner F, Azpiroz F. Metabolic adaptation of colonic microbiota to galactooligosaccharides: a proof-of-concept-study. Aliment Pharmacol Ther. 2017 Mar;45(5):670-680. doi: 10.1111/apt.13931. Epub 2017 Jan 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 26, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Estimate): December 1, 2015
• Last Update Submitted That Met QC Criteria: November 26, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Healthy subjects; microbiota; intestinal gas; prebiotics
• Other Study ID Numbers: PR(AG)296/2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No