Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
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
University of Virginia
60 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Positive glucose hydrogen breath test (GHBT)
- Weight-for-age Z score > -1
- Length-for-age Z score > -1
Exclusion Criteria5
- Presence of known chronic or congenital illness, including developmental delay
- Presence of acute gastrointestinal illness in the preceding 14 days
- Antibiotic use in the preceding 14 days
- Previous adverse reaction to any of the three study medications or other drugs in the same antibiotic classes
- Sibling previously enrolled in this study
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Interventions
8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
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
20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07451171