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
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
Treatments tested in this trial
- Trimethoprim-sulfamethoxazole (TMP/SMX)
- Metronidazole
- Amoxicillin-Clavulanate (4:1 formulation)
Treatment groups
Sponsors and collaborators
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