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

RecruitingPhase 2

Sponsor: University of Virginia

Conditions: Small Intestine Bacterial Overgrowth

Interventions: Trimethoprim-sulfamethoxazole (TMP/SMX), Metronidazole, Amoxicillin-Clavulanate (4:1 formulation)

Countries: Bangladesh

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 overview

Sex: ALL

Age: 1 Year to 2 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Dhaka, Bangladesh