Health Trials

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

ConditionSmall Intestine Bacterial Overgrowth
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-2
SponsorUniversity of Virginia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Positive glucose hydrogen breath test (GHBT)

Weight-for-age Z score > -1

Length-for-age Z score > -1

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: MetronidazoleExperimental treatment 1 intervention
Group B: Trimethoprim-sulfamethoxazole and MetronidazoleExperimental treatment 2 interventions
Group C: Amoxicillin-ClavulanateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at 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.

Time frame
Day 15

Secondary outcomes

1

Conversion to GHBT Negativity at 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.

Time frame
Day 45
2

Average Glucose Hydrogen Breath Test Area Under the Curve

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.

Time frame
Baseline, day 15, day 45
3

Fecal Myeloperoxidase

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

Time frame
Baseline, day 15, day 45
4

Fecal Neopterin

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

Time frame
Baseline, day 15, day 45

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

Virginia Commonwealth University

Collaborator

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

Collaborator

Source ClinicalTrials.gov
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