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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | 'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day |
|
| Synbiotic | Active Comparator | 'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Lactobacillus acidophilus NCFM and cellobiose | Dietary Supplement |
|
| 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) |
| 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) |
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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
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella C. van Zanten, PhD student | Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark | Principal Investigator |
| Gabriella C van Zanten, PhD student | Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen | Frederiksberg C | 1958 | Denmark |
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| ID | Term |
|---|---|
| D002475 | Cellobiose |
| ID | Term |
|---|---|
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
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