Intestinal Microbiota Adaptation to Prebiotic Administration

NCT ID: NCT04164914

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2020-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Prebiotic administration

Group Type: EXPERIMENTAL

Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Prebiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vall d'Hebron Research Institut

Barcelona, , Spain

Countries

Spain

Other Identifiers

PR(AG)420-2018

Identifier Type: -

Identifier Source: org_study_id