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

May 17, 2013 updated by: Daniel Merenstein, Georgetown University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • BB-12 probiotic supplemented yogurt
Placebo Comparator: 2. Placebo
Strawberry flavored yogurt
Drug: Placebo
Strawberry flavored yogurt
Other Names:
  • Strawberry flavored yogurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R21AT003600-01A1
  • IND # 13691 (Other Identifier: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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