Comparing three antibiotics for small intestine bacterial overgrowth in Bangladeshi children
A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth
This study tests which of three antibiotics—TMP/SMX, metronidazole, or amoxicillin-clavulanate—works best to treat small intestine bacterial overgrowth in children in Dhaka, Bangladesh.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 2 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT07451171 on ClinicalTrials.gov |
What this trial studies
In this Phase IIa interventional trial, children who test positive on a glucose hydrogen breath test for SIBO will receive one of three antibiotic regimens: trimethoprim-sulfamethoxazole (TMP/SMX), metronidazole, or amoxicillin-clavulanate (4:1). Eligible participants must have weight-for-age and length-for-age Z scores greater than -1 and must not have taken antibiotics or had acute gastrointestinal illness in the prior 14 days. Children with known chronic or congenital illness, developmental delay, recent antibiotic exposure, prior adverse reactions to the study drugs, or siblings already enrolled are excluded. The trial is run at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Dhaka with leadership from the University of Virginia and collaboration with NIH and other partners.
Who should consider this trial
Good fit: Children in Dhaka with a positive glucose hydrogen breath test for SIBO and weight- and length-for-age Z scores above -1, who have not used antibiotics or had acute GI illness in the prior 14 days, are ideal candidates.
Not a fit: Children with chronic or congenital illnesses, developmental delay, recent antibiotic use or acute gastrointestinal illness, prior adverse reactions to the study drugs, or siblings already enrolled are not expected to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify the most effective, locally available antibiotic regimen to clear SIBO and potentially improve gut health and growth in affected children.
How similar studies have performed: Antibiotics have been used to treat SIBO in other populations with some reported benefit, but comparative effectiveness for SIBO in impoverished Bangladeshi children and effects on growth remain not well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Jeffrey R Donowitz, MD — University of Virginia
- Study coordinator: Jeffrey R Donowitz, MD
- Email: jrd9d@virginia.edu
- Phone: 434-243-8824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.