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

Healthy Humans Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716910
• Other study ID #: DK-H-4-2010-137
• Status: Completed
• Phase: Phase 0
• First received: October 18, 2012
• Last updated: October 29, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: October 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Scientific Ethics Committee of Capital Region of Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Combination of Lactobacillus acidophilus NCFM and cellobiose

Locations

Country	Name	City	State
Denmark	Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No