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| ID | Type | Description | Link |
|---|---|---|---|
| PS Project 00090915 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Schwabe North America | INDUSTRY |
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Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.
The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hard shell gelatin capsules | Active Comparator |
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| Acidophilus pearls | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acidophilus pearls | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal survival of probiotics | The investigators will measure survival of the probiotics in fecal samples. | Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19 |
| Measure | Description | Time Frame |
|---|---|---|
| GI symptoms | Change in GI symptoms using a weekly questionnaire. | Day 7-9 and day 10-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal markers | The investigators will measure fecal markers. This includes stool consistency on Bristol scale and pH. | Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Mai, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emerging Pathogens Institute | Gainesville | Florida | 32610 | United States |
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| Hard shell gelatin capsules | Dietary Supplement |
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