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

Early Phase 1

Completed

• Conditions: Synbiotics; Healthy Humans; Composition of Gut Microbiota; Short and Branched-chain Fatty Acids
• Interventions: Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

• Registration Number: NCT01716910
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-29
• Last Update Submitted: 2012-10-29
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

healthy individuals between 18-50 years of age who had not used antibiotics three months prior to the trial

Exclusion Criteria

• chronic illness
• regular intake of medication (except birth-control pills)
• post-menopausal women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Combination of Lactobacillus acidophilus NCFM and cellobiose	'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day
Synbiotic	Combination of Lactobacillus acidophilus NCFM and cellobiose	'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU

Primary Outcome Measures

Name	Time	Method
increase in fecal butyrate concentration	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)

Secondary Outcome Measures

Name	Time	Method
changes in composition of microbiota	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	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)

Trial Locations

Locations (1)

Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen; 🇩🇰 Frederiksberg C, Denmark