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OpenTrials
Completed

NCT Number: NCT00848003

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

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.

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Key information

Conditions

Adults on Antibiotics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Amoxicillin
  • Augmentin (amoxicillin/clavulanate)
  • Ancef (cefazolin)
  • Cefadroxil
  • Cephalexin
  • Cephradine
  • Duricef (cefadroxil)
  • Keflex (cephalexin)
  • Kefzol (cefazolin)
  • Velosef (cephradine)
  • Ceclor (cefaclor)
  • Cefotan
  • Cefoxitin
  • Ceftin (cefuroxime)
  • Cefzil (cefprozil)
  • Lorabid (loracarbef)
  • Mefoxin (Cefoxitin)
  • Zinacef (cefuroxime)
  • Omnicef (cefdinir)
  • Suprax (cefixime)
  • Dicloxacillin
  • 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
  • Tetracycline
  • Erythromycin
  • Trimethoprim
  • 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.

Treatment and study plan

Bifidobacterium animalis subsp. lactis strain BB-12

Drug

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

Drug

Strawberry flavored yogurt

Other names: Strawberry flavored yogurt

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Medstar Health Research Institute

Registry information

Acronym: PHASE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 20, 2009
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.