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

Study Overview
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Brief Summary
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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
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Synbiotics, Healthy Humans, Composition of Gut Microbiota, Short and Branched-chain Fatty Acids

Intervention / Treatment
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* Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day | Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose<br> <br> |
| Active Comparator: Synbiotic<br>'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU | Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |