NCT07451171

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 1 Year – 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Intestine Bacterial Overgrowth

Interventions

Type	Name	Description
DRUG	Trimethoprim-sulfamethoxazole (TMP/SMX)	8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
DRUG	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
DRUG	Amoxicillin-Clavulanate (4:1 formulation)	20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Bangladesh