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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01716910

Enrollment

Registered

2012-10-30

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTCombination of Lactobacillus acidophilus NCFM and cellobiose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026