RecruitingPhase 2NCT07451171

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


Sponsor

University of Virginia

Enrollment

60 participants

Start Date

Apr 15, 2026

Study Type

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

Min Age: 1 YearMax Age: 2 Years

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

DRUGTrimethoprim-sulfamethoxazole (TMP/SMX)

8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim

DRUGMetronidazole

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

DRUGAmoxicillin-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

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NCT07451171