An Early Phase 1 interventional study of Combination of Lactobacillus acidophilus NCFM and cellobiose in Synbiotics, Healthy Humans and Composition of Gut Microbiota, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-30.
Sponsored by University of Copenhagen · Early Phase 1, Interventional, and Basic science
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.
University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Inclusion Criteria:healthy individuals between 18-50 years of age who had not used antibiotics three months prior to the trial
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Exclusion Criteria:
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day
Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU
Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose
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)
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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University of Copenhagen