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OpenTrials
Completed

NCT Number: NCT02618239

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

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

Treatment and study plan

Bimuno Galacto-oligo-saccharide

Dietary Supplement

Primary outcomes

  1. Number of daily anal gas evacuations

    Time frame: Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)

Secondary outcomes

  1. Volume of anal gas evacuation

    Time frame: Change from beginning of treatment (day 3) to end of treatment (day 21)

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 1, 2015
Registry last updated
Dec 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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