This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week clinical trial on healthy volunteers. Following a two week run-in-period, subjects were randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a 3-week wash-out period before the second treatment period, followed by a another wash-out period. Volunteers completed questionnaires for each period on overall health and well being, stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to collect fecal samples for investigation of microbiological and microbial metabolites before and after three treatment periods. The primary objective of the study is tan increase in fecal butyrate concentration. Secondary objectives are changes in microbiota composition and short-chain fatty acids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
18
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Frederiksberg C, Denmark
increase in fecal butyrate concentration
Time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
changes in composition of microbiota
Time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
changes in short-chain fatty acids
Time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
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