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

Phase 1

Completed

• Conditions: Adults on Antibiotics
• Interventions: Drug: Bifidobacterium animalis subsp. lactis strain BB-12; Drug: Placebo

• Registration Number: NCT00848003
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Study Start: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Active	Bifidobacterium animalis subsp. lactis strain BB-12	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	Strawberry flavored yogurt

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States