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| ID | Type | Description | Link |
|---|---|---|---|
| OCR26142 | Other Identifier | UF OnCore | |
| AGR00015606 | Other Identifier | UFIRST |
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| Name | Class |
|---|---|
| Lallemand Health Solutions, Inc. | UNKNOWN |
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The aims of this study are to determine how long it takes for the strains of a probiotic formulation to be detected in feces after the start of an intervention, how long they persist after the end of the intervention, and the associations between detection and persistence with total gut transit time.
This is a 10-week interventional, open-label pilot study designed to evaluate the detection and persistence of L. helveticus R-0052, L. casei NI319, B. breve NI337, and B. longum R-0175 strains in feces of healthy adults following the start and the end of IP intervention, respectively. This study will have an initial baseline period (4 weeks), a probiotic intervention (2 weeks) and a washout period (4 weeks). Participants will complete daily questionnaires regarding stool frequency, time of stool collections, and IP intake. A weekly Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be administered. Transit time will be assessed using radiopaque markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental | Healthy adults will be given probiotic strains to evaluate the detection and persistence of the strains in the participant's feces. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Strains | Biological | A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in time to detection of probiotic strains | using strain-specific qPCR assays. | Day 1; Day 2; Day 3, Day 4, Day 7, Day 10 |
| Change in time to non-detection (persistence) of probiotic strains | using strain-specific qPCR assays. | Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Whole gut transit time | Whole gut transit time measured by radiopaque marker recovery in intervention stools | Day 1, Day 2, Day 3, Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Dahl | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Science and Human Nutrition Department | Gainesville | Florida | 32611 | United States |
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