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Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children

NCT07451171 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jeffrey R Donowitz, MD · University of Virginia

  • Rashidul Haque, MBBS, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-18
Primary Completion
2026-11-02
Completion
2026-12-02

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07451171 on ClinicalTrials.gov