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

NCT ID: NCT02618239

Last Updated: 2015-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy subjects

Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks

Group Type EXPERIMENTAL

Bimuno Galacto-oligo-saccharide

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Bimuno Galacto-oligo-saccharide

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* gastrointestinal symptoms
* recent (3 months) antibiotic intake
* recent (3 months) change of diet
* recent (3 months) gastroenteritis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Azpiroz, MD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Research Institute

References

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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.

Reference Type DERIVED
PMID: 28078750 (View on PubMed)

Other Identifiers

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PR(AG)296/2013

Identifier Type: -

Identifier Source: org_study_id