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

NCT01716910 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-10-30

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Combination of Lactobacillus acidophilus NCFM and cellobiose

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Gabriella C. van Zanten, PhD student · Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark

  • Gabriella C van Zanten, PhD student · Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716910 on ClinicalTrials.gov