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

University of Copenhagen

Status and phase: Completed; Early Phase 1

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

Treatments: Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

Study type: Interventional

Funder types: Other

Identifiers

NCT01716910

DK-H-4-2010-137

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

Maltodextrin

Placebo Comparator group

Description:

'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day

Treatment:

Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

Synbiotic

Active Comparator group

Description:

'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU

Treatment:

Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose