NCT03181516

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Bifidobacterium animalis subsp. lactis BB-12	Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
OTHER	Control	Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Timeline

• Start date: 2017-09-30
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2017-06-08
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study