At a glance
ClinicalIndex Comparison Record- ✓Age 3–12 years
- ✓Enrollment within 24 hours of starting antibiotics
- ✓Prescribed penicillin or cephalosporin class antibiotic for 7–10 days for respiratory infection
- ✓Outpatient treatment
- ✕Developmental delays
- ✕Any chronic condition requiring medication (e.g., diabetes, asthma)
- ✕Prematurity (born before 37 weeks gestation)
- ✕Congenital anomalies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
In Brief
A Phase 2 clinical trial evaluating Bifidobacterium animalis subsp. lactis BB-12 and Control for Antibiotic-associated Diarrhea. Completed, enrolled 255 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
Yogurt without Bifidobacterium animalis subsp. lactis BB-12