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

V

Vall d'Hebron University Hospital (HUVH)

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Bimuno Galacto-oligo-saccharide

Study type

Interventional

Funder types

Other

Identifiers

NCT02618239
PR(AG)296/2013

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Healthy subjects
Experimental group
Description:
Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks
Treatment:
Dietary Supplement: Bimuno Galacto-oligo-saccharide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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