Intestinal Microbiota Adaptation to Prebiotic Administration

Healthy Clinical Trial

Official title:

Intestinal Microbiota Adaptation to Prebiotic Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164914
• Other study ID #: PR(AG)420-2018
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• gastrointestinal symptoms

• recent (3 months) antibiotic intake

• change in dietary habits 4 weeks before

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Prebiotic
Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institut	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Microbiota composition by fecal analysis	Change from beginning of treatment to end of treatment	28 days