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

Sponsors and Collaborators:	Georgetown University Medstar Research Institute
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00848003

Sponsors and Collaborators:

Georgetown University
Medstar Research Institute

Information provided by:

Georgetown University

ClinicalTrials.gov Identifier:

NCT00848003

Purpose

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.

Condition	Intervention	Phase
Adults on Antibiotics	Dietary Supplement: Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Dietary Supplement: Placebo	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Active: Experimental Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days	Dietary Supplement: Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days
2. Placebo: Placebo Comparator Strawberry flavored yogurt	Dietary Supplement: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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
1. Tetracycline
2. Erythromycin
3. Trimethoprim
4. 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.

Responsible Party:	Assistant Professor, Director of Research Programs ( Daniel J. Merenstein )
Study ID Numbers:	R21AT003600-01A1, IND # 13691
Study First Received:	February 18, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848003 History of Changes
Health Authority:	United States: Food and Drug Administration

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007