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Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618239
Enrollment
20
Registered
2015-12-01
Start date
2013-11-30
Completion date
2014-05-31
Last updated
2015-12-01

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 changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics. Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, 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_SUPPLEMENTBimuno Galacto-oligo-saccharide

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 * recent (3 months) change of diet * recent (3 months) gastroenteritis

Design outcomes

Primary

MeasureTime frame
Number of daily anal gas evacuationsChange from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)

Secondary

MeasureTime frame
Volume of anal gas evacuationChange from beginning of treatment (day 3) to end of treatment (day 21)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026