Healthy Clinical Trial
Official title:
Intestinal Microbiota Adaptation to Prebiotic Administration
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.
n/a
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