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Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

December 30, 2019

Overview

This study investigates how probiotic BB-12 supplemented yogurt can help prevent antibiotic-associated diarrhea (AAD) in children ages 3-12. Investigators will monitor the safety of the probiotics and evaluate the fecal microbiota to gauge the impact on development of AAD.

 

Study Information

Investigators are looking for 300 participants who will be split up into experimental and control groups. Both groups will receive yogurt but the experimental group will receive yogurt with BB-12 supplements. Investigators will look at the time frame of the diarrhea, the quality of life score, and symptom progression for the participants in the ensuing 1-2 weeks.

 

Inclusion Criteria

 

  • Child is between ages of 3-12 years
  • Caregiver has the ability to read, speak and write English or Spanish
  • Household has refrigerator for proper storage of drink
  • Household has telephone access
  • Enrollment must take place within 24 hours of starting antibiotics
  • Child was outpatient treated
  • Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 10 days for a respiratory infection;

 

Exclusion Criteria

 

  • Developmental delays
  • Any chronic condition, such as diabetes or asthma, that requires medication
  • Prematurity, or born prior to 37 weeks gestation/of pregnancy
  • Congenital anomalies
  • Failure to thrive
  • Allergy to strawberry
  • Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
  • Any other medicines used except antipyretic medicines (pro re nata concomitant medications are allowed)
  • Parental belief of lactose intolerance
  • History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
  • History of gastrointestinal surgery or disease
  • Milk-protein allergy
  • Allergy to any component of the product or the yogurt vehicle
  • Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
  • Allergy to any of the following medications: Tetracycline, Erythromycin, Trimethoprim, Ciprofloxacin

 

Location

Georgetown University Department of Family Medicine, Research Division

Washington, District of Columbia, United States, 20007

Contact: Dan Merenstein, MD        

Principal Investigator: Dan Merenstein, MD      

 

Sponsors/Collaborators

Georgetown University

University of Maryland, Baltimore

Penn State University

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