NCT01716910

Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Synbiotics
• Healthy Humans
• Composition of Gut Microbiota
• Short and Branched-chain Fatty Acids

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Combination of Lactobacillus acidophilus NCFM and cellobiose

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2012-10-30
• Last updated: 2012-10-30

Locations

1 site across 1 country: Denmark