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

Georgetown University

Status and phase: Completed; Phase 1

Conditions: Adults on Antibiotics

Treatments: Drug: Placebo; Drug: Bifidobacterium animalis subsp. lactis strain BB-12

Study type: Interventional

Funder types: Other

Identifiers

NCT00848003

R21AT003600-01A1

IND # 13691 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1. Active

Active Comparator group

Description:

Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days

Treatment:

Drug: Bifidobacterium animalis subsp. lactis strain BB-12

2. Placebo

Placebo Comparator group

Description:

Strawberry flavored yogurt

Treatment:

Drug: Placebo