Tropical Enteropathy
Conditions
Brief summary
The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.
Interventions
DRUGRifaximin
100mg of rifaxin for 7 consecutive days, twice daily
DRUGPlacebo
twice daily for 7 consecutive days
Sponsors
Baylor College of Medicine
Kamuzu University of Health Sciences
United States Department of Agriculture (USDA)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* live in single village
Exclusion criteria
* acutely malnourished * acutely ill * chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Urinary L:M Ratio Before and After the Intervention | 28 days | To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later. |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rifaximin Allocated to rifaximin | 72 |
| Placebo Allocated to placebo | 72 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Analysis | Lactulose unable to be detected in urine | 2 | 1 |
Baseline characteristics
| Characteristic | Rifaximin | Placebo | Total |
|---|---|---|---|
| Age, Customized Age | 47.6 Months STANDARD_DEVIATION 6.5 | 46.8 Months STANDARD_DEVIATION 7.6 | 47.2 Months STANDARD_DEVIATION 7.6 |
| Sex: Female, Male Female | 32 Participants | 29 Participants | 61 Participants |
| Sex: Female, Male Male | 40 Participants | 43 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
Primary
Difference in the Urinary L:M Ratio Before and After the Intervention
To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximin | Difference in the Urinary L:M Ratio Before and After the Intervention | -0.01 Ratio of lactulose-to-mannitol (L:M) exc | Standard Deviation 0.12 |
| Placebo | Difference in the Urinary L:M Ratio Before and After the Intervention | 0.02 Ratio of lactulose-to-mannitol (L:M) exc | Standard Deviation 0.16 |