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

This study has been completed.
Medstar Health Research Institute
Information provided by (Responsible Party):
Daniel Merenstein, Georgetown University Identifier:
First received: February 18, 2009
Last updated: May 17, 2013
Last verified: May 2013

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 Drug: Bifidobacterium animalis subsp. lactis strain BB-12 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

Resource links provided by NLM:

Further study details as provided by Daniel Merenstein, 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 ]

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 ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Active

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
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
Other Name: BB-12 probiotic supplemented yogurt
Placebo Comparator: 2. Placebo
Strawberry flavored yogurt
Drug: Placebo
Strawberry flavored yogurt
Other Name: Strawberry flavored yogurt


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  1. Amoxicillin
  2. Augmentin (amoxicillin/clavulanate)
  3. Ancef (cefazolin)
  4. Cefadroxil
  5. Cephalexin
  6. Cephradine
  7. Duricef (cefadroxil)
  8. Keflex (cephalexin)
  9. Kefzol (cefazolin)
  10. Velosef (cephradine)
  11. Ceclor (cefaclor)
  12. Cefotan
  13. Cefoxitin
  14. Ceftin (cefuroxime)
  15. Cefzil (cefprozil)
  16. Lorabid (loracarbef)
  17. Mefoxin (Cefoxitin)
  18. Zinacef (cefuroxime)
  19. Omnicef (cefdinir)
  20. Suprax (cefixime)
  21. Dicloxacillin
  22. 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.
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Please refer to this study by its identifier: NCT00848003

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Medstar Health Research Institute
  More Information

Heath and Nutritional Properties of Probiotics in Food Including Powder Milk With Live Lactic Acid Bacteria: Food and Agriculture Organization of the United Nations and World Health Organization2005; 2001.
Research MM. The Live Active Culture Yogurt Survey. Monroe Mendelsohn Research. Available at: Accessed May 24, 2005.
Meile L, Ludwig W, Rueger U, et al. Bifidobacterium lactis sp. nov., a moderately oxygen tolerant species isolated from fermented milk. Syst. Appl. Microbiol. 1997(20):57-46.
Fukushima Y, Kwata Y, H H. Effect of a probiotic formula containing bifidobacteria (Nan BF) on fecal flora and fecal metaboiltes in healthy children. Bioscience Microflora. 1997(16):65-72.
Hasler CM. Functional Foods: Their Role in Diease Prevention and Health Promotion. Food Technology. 1998;52(2):57-62.
Alm L, Ryd-Kjellen E, Setterberg G, Blomquist L. Effect of a new fermented milk product
Black FT, Anderson PL, Orskov J, Orskov F, Gaarslev K, Laulund S. Prophylactic efficacy of lactobacilli on traveler's diarrhea. Travel Medicine. 1989:333-335.
Kankaanpaa P, Sutas Y, Salminen S, Isolauri E. Results on clinical demonstration of probiotics on children. Paper presented at: Presented at Functional Food Research in Europe, Third Workshop, 1998; Probdemo, Finland, October 1-2.
Amrouche T, Boutin Y, Fliss I. Effects of bifidobacterial cytoplasm peptide and protein fractions on mouse lymphocyte proliferation and cytokine production. Food and Agricultural Immunology. MAR 2006;17(1):29-42.
Amrouche T, Boutin Y, Prioult G, Fliss I. Effects of bifidobacterial cytoplasm, cell wall and exopolysaccharide on mouse lymphocyte proliferation and cytokine production. International Dairy Journal. JAN 2006;16(1):70-80.
Obradovic D, Curic M, Ivanovic M, Trbojevic B, Djordjevic M. Probiotic function of the fermented milk Jogurt Plus. Paper presented at: FEMS Conference (Fifthe Symposium on Lactic Acid Bacteria), 1996; Holland. September 8-12.
Salminen S, Laine M, von Wright A, Vuopio-Varkila J, Kohonen T, Mattila-Sandholm T. Development of selection criteria for probiotic strains to assess their potential in functional foods: A Nordic and European approach. Bioscience Microflora. 1996;15(2):61-67.
Black FT, Laulund S. A study on the recovery of ingested, encapsulated Lactobacillus acidophilus and Bifidobacteria bifidum from doudenal fluid and faeces. Chr. Hansen Internal Report. 1988.
Abi-Hanna A, Moore N, Yolken RH, Saavedra JM. Long term consumption of infant formulas with live probiotic bacteria: safety and tolerance. Journal of Pediatric Gastroenterology and Nutrition. 1998;27(4):484.
Lourens-Hattingh A, Viljoen BC. Yogurt as probiotic carrier food. International Dairy Journal. 2001;11(1-2):1-17.
Nevins TE.

Responsible Party: Daniel Merenstein, Principal Investigator, Georgetown University Identifier: NCT00848003     History of Changes
Other Study ID Numbers: R21AT003600-01A1
IND # 13691 ( Other Identifier: FDA )
Study First Received: February 18, 2009
Last Updated: May 17, 2013

Keywords provided by Daniel Merenstein, Georgetown University:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on August 18, 2017