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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| Kamuzu University of Health Sciences | OTHER |
| United States Department of Agriculture (USDA) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 100mg of rifaxin for 7 consecutive days, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limela | Malawi |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin | Allocated to rifaximin |
| FG001 | Placebo | Allocated to placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized and Allocation |
| |||||||||||||
| Analysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin | Allocated to rifaximin |
| BG001 | Placebo | Allocated to placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Ratio of lactulose-to-mannitol (L:M) exc | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin | Allocated to rifaximin | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Manary | Washington University School of Medicine in St. Louis | 314 454-2178 | manary@kids.wustl.edu |
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| ID | Term |
|---|---|
| D013182 | Sprue, Tropical |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
twice daily for 7 consecutive days |
|
| NOT COMPLETED |
|
|
| Total |
Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Allocated to placebo |
|
|
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Placebo | Allocated to placebo | 0 | 72 | 0 | 72 | 0 | 72 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |