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Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Sponsor: University of Virginia
Summary
The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.
Official title: A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth
Key Details
Gender
All
Age Range
1 Year - 2 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04
Completion Date
2026-06
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Trimethoprim-sulfamethoxazole (TMP/SMX)
8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
Metronidazole
Administered alone: 20-30 mg/kg/day divided every 8 hours, with a maximum 750 mg/dose Co-administered with Trimethoprim-sulfamethoxazole: 35-50 mg/kg/day divided every 8 hours, with a maximum 750 mg/dose
Amoxicillin-Clavulanate (4:1 formulation)
20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg
Locations (1)
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh