Intestinal Microbiota Adaptation to Prebiotic Administration
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Apr 2019
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2019
CompletedFirst Submitted
Initial submission to the registry
November 13, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 15, 2020
July 1, 2020
1 year
November 13, 2019
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Volume of anal gas evacuation
28 days
Microbiota composition by fecal analysis
28 days
Study Arms (1)
Healthy subjects
EXPERIMENTALPrebiotic administration
Interventions
Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)
Eligibility Criteria
You may not qualify if:
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- change in dietary habits 4 weeks before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vall d'Hebron Research Institut
Barcelona, 08035, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2019
First Posted
November 15, 2019
Study Start
April 29, 2019
Primary Completion
April 30, 2020
Study Completion
June 30, 2020
Last Updated
July 15, 2020
Record last verified: 2020-07