Intestinal Microbiota Adaptation to Prebiotic Administration

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04164914
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Prebiotic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Intestinal Microbiota Adaptation to Prebiotic Administration
• Actual Study Start Date: Apr 29, 2019
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy subjects Prebiotic administration	Dietary Supplement: Prebiotic; Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Microbiota composition by fecal analysis [28 days]

   Change from beginning of treatment to end of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Exclusion Criteria:

• gastrointestinal symptoms

• recent (3 months) antibiotic intake

• change in dietary habits 4 weeks before

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebron Research Institut	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT04164914
• Other Study ID Numbers: PR(AG)420-2018
• First Posted: Nov 15, 2019
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: intestinal gas; healthy subjects; microbiota; prebiotics

Study Results

No Results Posted as of Jul 15, 2020