An interventional study of Rifaximin and Placebo in Tropical Enteropathy, sponsored by Washington University School of Medicine. Completed at 1 site in Malawi. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 147 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Drug: Rifaximin
Drug: Placebo
100mg of rifaxin for 7 consecutive days, twice daily
twice daily for 7 consecutive days
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
| Milestone | Rifaximin | Placebo |
|---|---|---|
| Started | 74 | 73 |
| Completed | 74 | 73 |
| Not completed | 0 | 0 |
| Milestone | Rifaximin | Placebo |
|---|---|---|
| Started | 74 | 73 |
| Completed | 72 | 72 |
| Not completed | 2 | 1 |
| Withdrew: Lactulose unable to be detected in urine | 2 | 1 |
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.
| Ratio of lactulose-to-mannitol (L:M) exc | Rifaximin | Placebo |
|---|---|---|
| Difference in the Urinary L:M Ratio Before and After the Intervention | -0.01 ± 0.12 | 0.02 ± 0.16 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rifaximin | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Placebo | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Age, Customized(Months) | Rifaximin | Placebo | Total |
|---|---|---|---|
| Age | 47.6 ± 6.5 | 46.8 ± 7.6 | 47.2 ± 7.6 |
| Sex: Female, Male(Participants) | Rifaximin | Placebo | Total |
|---|---|---|---|
| Female | 32 | 29 | 61 |
| Male | 40 | 43 | 83 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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