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

NCT ID: NCT00848003

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Adults on Antibiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bifidobacterium animalis subsp. lactis strain BB-12

Intervention Type: DRUG

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

2. Placebo

Strawberry flavored yogurt

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Strawberry flavored yogurt

Interventions

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

Intervention Type: DRUG

Placebo

Strawberry flavored yogurt

Intervention Type: DRUG

Other Intervention Names

BB-12 probiotic supplemented yogurt; Strawberry flavored yogurt

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Merenstein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

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Other Identifiers

IND # 13691

Identifier Type: OTHER

Identifier Source: secondary_id

R21AT003600-01A1

Identifier Type: -

Identifier Source: org_study_id