Small Intestine Bacterial Overgrowth
Conditions
Keywords
environmental enteric dysfunction
Brief summary
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.
Interventions
8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
DRUGMetronidazole
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
DRUGAmoxicillin-Clavulanate (4:1 formulation)
20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg
Sponsors
University of Virginia
National Institutes of Health (NIH)
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at Day 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to GHBT Negativity at Day 45 | Day 45 | 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. |
| Average Glucose Hydrogen Breath Test Area Under the Curve | Baseline, day 15, day 45 | 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. |
| Fecal Myeloperoxidase | Baseline, day 15, day 45 | Fecal myeloperoxidase levels as measured by a commercially available ELISA kit. |
| Fecal Neopterin | Baseline, day 15, day 45 | Fecal neopterin levels as measured by a commercially available ELISA kit. |
| Fecal Calprotectin | Baseline, day 15, day 45 | Fecal calprotectin levels as measured by a commercially available ELISA kit. |
Countries
Bangladesh
Contacts
CONTACTJeffrey R Donowitz, MD
PRINCIPAL_INVESTIGATORJeffrey R Donowitz, MD
University of Virginia
PRINCIPAL_INVESTIGATORRashidul Haque, MBBS, PhD
International Centre for Diarrhoeal Disease Research, Bangladesh
Outcome results
None listed