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During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.
Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butyricicoccus pullicaecorum | Active Comparator | Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating. |
|
| Placebo (maltodextrin) | Placebo Comparator | Lyophilized maltodextrin, encapsulated with a pH-resistent coating. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butyricicoccus pullicaecorum 25-3T | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities | 1 year | |
| The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KULeuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin |
| Other |
|
| 1 year |