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

This study has been completed.
Sponsor:
Collaborator:
Medstar Research Institute
Information provided by (Responsible Party):
Daniel Merenstein, Georgetown University
ClinicalTrials.gov Identifier:
NCT00848003
First received: February 18, 2009
Last updated: May 17, 2013
Last verified: May 2013
  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
Drug: Bifidobacterium animalis subsp. lactis strain BB-12
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ]

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

  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848003

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

Publications:
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.
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.
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.
Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. Jun 2005;115(6):e718-724.

Responsible Party: Daniel Merenstein, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT00848003     History of Changes
Other Study ID Numbers: R21AT003600-01A1, IND # 13691
Study First Received: February 18, 2009
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
Probiotics
BB-12
Yogurt
Antibiotics

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 22, 2014