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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: Completed NA study, sponsored by University of Florida.
NCT02001610 is a NA study that has completed, run by University of Florida. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 (Unpublished studies conducted at SNA research facility, February, 2010.)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.
Primary Outcome
The investigators will measure survival of the probiotics in fecal samples.
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 |
What the finished NCT02001610 record still lists
NCT02001610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Acidophilus pearls is the first listed.
NCT02001610 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02001610's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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