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NCT00848003 · ClinicalTrials.gov registry record · Phase 1
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00848003: Completed Phase 1 study, sponsored by Georgetown University.
NCT00848003 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00848003, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
We believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food. More specifically, the rationale for this Phase I study is to determine safety of our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study. We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
Interventions
- DRUG Placebo
- DRUG Bifidobacterium animalis subsp. lactis strain BB-12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT00848003 record still lists
NCT00848003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00848003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00848003 about?
NCT00848003 is a clinical study titled "Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics". We believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to ...
What is the current status of trial NCT00848003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2009-10. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00848003?
The interventions under investigation include: Placebo (DRUG), Bifidobacterium animalis subsp. lactis strain BB-12 (DRUG).
Who is sponsoring clinical trial NCT00848003?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00848003's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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