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Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2309 | Experimental | 4 capsules daily for 12 weeks |
|
| Nutrof Total | Active Comparator | 2 capsules daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2309 | Other | Food for Special Medical Purpose / 4 capsules daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerance assessment | Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the Bristol Stool Scale (BSS) (composite score of stool frequency and consistency) and 10-point Likert scales filled (sum of the ratings of the 4 gastrointestinal symptoms scores) daily for 1 week prior to the completion of the 12-week treatment period (expressed in arbitrary unit/day (a.u./day), range 0-50) | 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Composite score of gastrointestinal tolerance | Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the BSS and 10-point Likert scales filled daily for 1 week prior to the completion of the 6-week treatment period (a.u./day, range 0-50) | 6 weeks |
| Each component of the composite score of gastrointestinal tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Investigation Clinique | Nantes | France |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 21, 2022 | |
| Reset | Jun 6, 2023 | |
| Release | Jun 16, 2023 | |
| Reset | Feb 8, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 21, 2022 | Jun 6, 2023 | |||
| Jun 16, 2023 |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutrof Total |
| Dietary Supplement |
2 capsules daily for 12 weeks |
|
|
Change from baseline in the mean of each component of the composite score of gastrointestinal tolerance after 6 weeks and 12 weeks of treatment: 4 gastrointestinal symptoms (a.u./day, range 0-10), stool frequency (number of stools/day), stool consistency (a.u./stool, range 1-7) |
| 6 weeks and 12 weeks |
| Acceptability | Assessed by a self-questionnaire to measure the global satisfaction (4-point scales) | 6 weeks and 12 weeks |
| Feb 8, 2024 |