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Completed

NCT Number: NCT04164914

Intestinal Microbiota Adaptation to Prebiotic Administration

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 whether a prebiotic induces adaptive changes in metabolic activity of gut microbiota and colonic biomass that explain its beneficial effect on gas-related symptoms.

Single-centre, single arm, open label, proof-of-concept study in healthy subjects. The study will consist of a pre-administration phase (2 wk), an administration phase (4 wk) and a post-administration phase (2 wk). A soluble prebiotic fiber (resistant dextrin 14 g/d) will be administered during the 4 wk administration phase. During 4 days immediately before, at the beginning and at the end of the administration phase and at the end of the post-administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days 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

Primary location

Vall d'Hebron Research Institut

Barcelona, 08035, Spain

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
  • change in dietary habits 4 weeks before

Treatment and study plan

Prebiotic

Dietary Supplement

Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)

Primary outcomes

  1. Number of daily anal gas evacuations

    Time frame: 28 days

    Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

Secondary outcomes

  1. Volume of anal gas evacuation

    Time frame: 28 days

    Change in the volume of anal gas evacuated for 4 hours after a probe meal from beginning of treatment to end of treatment

  2. Microbiota composition by fecal analysis

    Time frame: 28 days

    Change from beginning of treatment to end of treatment

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Jul 15, 2020

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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