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

August 14, 2026 updated by: Jeffrey Donowitz, MD, University of Virginia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Recruiting
        • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
        • Contact:
          • Rashidul Haque, MBBS, PhD
          • Phone Number: 3483 880-0171-3093859
          • Email: rhaque@icddrb.org
        • Contact:
        • Principal Investigator:
          • Rashidul Haque, MBBS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Positive glucose hydrogen breath test (GHBT)
  • Weight-for-age Z score > -1
  • Length-for-age Z score > -1

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metronidazole
14-day oral course
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
Experimental: Trimethoprim-sulfamethoxazole and Metronidazole
14-day oral course
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: Trimethoprim-sulfamethoxazole (TMP/SMX)
8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
Experimental: Amoxicillin-Clavulanate
14-day oral course
Drug: Amoxicillin-Clavulanate (4:1 formulation)
20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at Day 15
Time Frame: Day 15
GHBT negativity will be defined as no breath hydrogen value ≥20 ppm over the patient's baseline during the course of the test. If any breath hydrogen value during the GHBT is >20 ppm over the patient's baseline, the test will be deemed positive.
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to GHBT Negativity at Day 45
Time Frame: Day 45
GHBT negativity will be defined as no breath hydrogen value ≥20 ppm over the patient's baseline during the course of the test. If any breath hydrogen value during the GHBT is >20 ppm over the patient's baseline, the test will be deemed positive.
Day 45
Average Glucose Hydrogen Breath Test Area Under the Curve
Time Frame: Baseline, day 15, day 45
Area under the hydrogen curve will be calculated at baseline, day 15, and day 45. An average of these values will be taken to construct this variable.
Baseline, day 15, day 45
Fecal Myeloperoxidase
Time Frame: Baseline, day 15, day 45
Fecal myeloperoxidase levels as measured by a commercially available ELISA kit.
Baseline, day 15, day 45
Fecal Neopterin
Time Frame: Baseline, day 15, day 45
Fecal neopterin levels as measured by a commercially available ELISA kit.
Baseline, day 15, day 45
Fecal Calprotectin
Time Frame: Baseline, day 15, day 45
Fecal calprotectin levels as measured by a commercially available ELISA kit.
Baseline, day 15, day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University

Investigators

  • Principal Investigator: Jeffrey R Donowitz, MD, University of Virginia
  • Principal Investigator: Rashidul Haque, MBBS, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2026

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

December 2, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302580
  • 1R01HD113733-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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