Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 9:24 PM
Study NCT ID:
NCT00848003
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2009-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHASE
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IND # 13691 | OTHER | FDA | View |