Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics (NCT03181516) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
United States255 participantsStarted 2017-09-30
Plain-language summary
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.
Who can participate
Age range3 Years – 12 Years
SexALL
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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 7-10 days for a respiratory infection;
✓. Amoxicillin
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