Intestinal Microbiota Adaptation to Prebiotic Administration

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Prebiotic

• Registration Number: NCT04164914
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-29
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Exclusion Criteria

• gastrointestinal symptoms
• recent (3 months) antibiotic intake
• change in dietary habits 4 weeks before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Prebiotic	Prebiotic administration

Primary Outcome Measures

Name	Time	Method
Number of daily anal gas evacuations	28 days	Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

Secondary Outcome Measures

Name	Time	Method
Volume of anal gas evacuation	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
Microbiota composition by fecal analysis	28 days	Change from beginning of treatment to end of treatment

Trial Locations

Locations (1)

Vall d'Hebron Research Institut; 🇪🇸 Barcelona, Spain