A Phase 1 interventional study of Bifidobacterium animalis subsp. lactis strain BB-12 and Placebo in Adults on Antibiotics, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-20.
Sponsored by Georgetown University · Phase 1, Interventional, and Prevention
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.
Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
The following is a list of inclusive antibiotics:
Pen-Vee K (penicillin)
Exclusion Criteria:
Allergy to any of the following medications
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days
Drug: Bifidobacterium animalis subsp. lactis strain BB-12
Strawberry flavored yogurt
Drug: Placebo
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
Also known as: BB-12 probiotic supplemented yogurt
Strawberry flavored yogurt
Also known as: Strawberry flavored yogurt
The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics.
Time frame: 1 year
In addition to safety diary, participants will keep a daily diary to track number of bowel movements, if drink was consumed, if illness resulted in change in activity, over-the-counter medicines used and other illness symptoms.
Time frame: 1 year
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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