NCT Number: NCT02618239
Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
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.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- recent (3 months) change of diet
- recent (3 months) gastroenteritis
Treatment and study plan
Primary outcomes
-
Number of daily anal gas evacuations
Time frame: Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)
Secondary outcomes
-
Volume of anal gas evacuation
Time frame: Change from beginning of treatment (day 3) to end of treatment (day 21)
Sponsors and collaborators
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 1, 2015
- Registry last updated
- Dec 1, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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