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

Phase 2Not Yet RecruitingNCT07451171

University of Virginia60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Small Intestine Bacterial Overgrowth

Interventions

Trimethoprim-sulfamethoxazole (TMP/SMX)DRUG

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

MetronidazoleDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

Outcomes

Primary Outcomes

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

Conversion to GHBT Negativity at Day 45

Time frame: Day 45

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

Fecal Myeloperoxidase

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

Time frame: Baseline, day 15, day 45

Fecal Neopterin

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

Time frame: Baseline, day 15, day 45

Fecal Calprotectin

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

Time frame: Baseline, day 15, day 45

Central Contacts

Jeffrey R Donowitz, MD

CONTACT

434-243-8824 jrd9d@virginia.edu

Data from ClinicalTrials.gov

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