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NCT Number: NCT07451171

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

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.

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Key information

Conditions

Small Intestine Bacterial Overgrowth

Age range

1 year–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim-sulfamethoxazole (TMP/SMX)

Drug

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

Metronidazole

Drug

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

Amoxicillin-Clavulanate (4:1 formulation)

Drug

20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Fecal Myeloperoxidase

    Time frame: Baseline, day 15, day 45

    Fecal myeloperoxidase levels as measured by a commercially available ELISA kit.

  4. Fecal Neopterin

    Time frame: Baseline, day 15, day 45

    Fecal neopterin levels as measured by a commercially available ELISA kit.

  5. Fecal Calprotectin

    Time frame: Baseline, day 15, day 45

    Fecal calprotectin levels as measured by a commercially available ELISA kit.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey R Donowitz, MD

CONTACT

[email protected]

434-243-8824

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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