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NCT02001610 · ClinicalTrials.gov registry record · NA
Acidophilus Pearls Fecal Recovery Study
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02001610 is a NA study that has completed, run by University of Florida. The registered enrollment target is 13 participants.
The verdict
NCT02001610, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
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 (Unpublished studies conducted at SNA research facility, February, 2010.)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.
Interventions
- DIETARY_SUPPLEMENT Acidophilus pearls
- DIETARY_SUPPLEMENT Hard shell gelatin capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02001610
The ClinicalTrials.gov registry entry for NCT02001610 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acidophilus pearls is the first listed.
NCT02001610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02001610 about?
NCT02001610 is a clinical study titled "Acidophilus Pearls Fecal Recovery Study". 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 ther...
What is the current status of trial NCT02001610?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2014-03. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02001610?
The interventions under investigation include: Acidophilus pearls (DIETARY_SUPPLEMENT), Hard shell gelatin capsules (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02001610?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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