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OpenTrials
Completed

NCT Number: NCT01716910

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen

Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination of Lactobacillus acidophilus NCFM and cellobiose

Dietary Supplement

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 30, 2012
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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