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

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

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

60 Participants
are divided into 3 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