Intestinal Microbiota Adaptation to Prebiotic Administration

Study Overview
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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 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.

Official Title
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Intestinal Microbiota Adaptation to Prebiotic Administration

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Prebiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: gastrointestinal symptoms recent (3 months) antibiotic intake change in dietary habits 4 weeks before

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>Prebiotic administration | Dietary Supplement: Prebiotic<br>* Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of daily anal gas evacuations | Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of anal gas evacuation | Change in the volume of anal gas evacuated for 4 hours after a probe meal from beginning of treatment to end of treatment | 28 days | 
| Microbiota composition by fecal analysis | Change from beginning of treatment to end of treatment | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal gas, healthy subjects, microbiota, prebiotics