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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 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 40 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00848003
The ClinicalTrials.gov registry entry for NCT00848003 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00848003 reports 0 study locations.
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.
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