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Intestinal Microbiota Adaptation to Prebiotic Administration

Intestinal Microbiota Adaptation to Prebiotic Administration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04164914
Enrollment
20
Registered
2019-11-15
Start date
2019-04-29
Completion date
2020-06-30
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

intestinal gas, healthy subjects, microbiota, prebiotics

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.

Interventions

DIETARY_SUPPLEMENTPrebiotic

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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

\-

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of daily anal gas evacuations28 daysChange in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

Secondary

MeasureTime frameDescription
Volume of anal gas evacuation28 daysChange 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 analysis28 daysChange from beginning of treatment to end of treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026