Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

Study Overview
=================
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.

Official Title
-----------------
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

Conditions
-----------------
Adults on Antibiotics

Intervention / Treatment
-----------------
* Drug: Bifidobacterium animalis subsp. lactis strain BB-12
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to speak and write English or Spanish Refrigerator for proper storage of drink Telephone access Enrollment must take place within 24 hours of starting antibiotics Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection; The following is a list of inclusive antibiotics: Amoxicillin Augmentin (amoxicillin/clavulanate) Ancef (cefazolin) Cefadroxil Cephalexin Cephradine Duricef (cefadroxil) Keflex (cephalexin) Kefzol (cefazolin) Velosef (cephradine) Ceclor (cefaclor) Cefotan Cefoxitin Ceftin (cefuroxime) Cefzil (cefprozil) Lorabid (loracarbef) Mefoxin (Cefoxitin) Zinacef (cefuroxime) Omnicef (cefdinir) Suprax (cefixime) Dicloxacillin Pen-Vee K (penicillin) Antibiotic prescribed at least twice a day Outpatients Exclusion Criteria: Chronic conditions, such as diabetes or asthma, that require daily medication Allergy to strawberry Active diarrhea Allergy to penicillin class antibiotic Any other medicines used except prescribed antibiotic and anti-pyretic medicines Allergy to any of the following medications Tetracycline Erythromycin Trimethoprim Ciprofloxacin Lactose intolerance. During baseline physical exam, any of the following will be grounds for exclusion; systolic blood pressure>140, systolic blood pressure <90, diastolic >90, oxygen saturation <98%, pulse rate >100, pulse rate <55 and respiratory rate >17. These include all vital signs that fall outside of the normal range, including Grade 1 through Grade 4.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Active<br>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<br>* Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days<br>* Other names: BB-12 probiotic supplemented yogurt;|
| Placebo Comparator: 2. Placebo<br>Strawberry flavored yogurt | Drug: Placebo<br>* Strawberry flavored yogurt<br>* Other names: Strawberry flavored yogurt;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, BB-12, Yogurt, Antibiotics