Trial of Rifaximin in the Treatment of Tropical Enteropathy

NCT00858988 | Completed Results

• 1 other identifier: MJM-rifaximin
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Tropical Enteropathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rifaximin

EXPERIMENTAL

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rifaximin DRUG

100mg of rifaxin for 7 consecutive days, twice daily

Rifaximin

Placebo DRUG

twice daily for 7 consecutive days

Placebo

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• live in single village

You may not qualify if:

• acutely malnourished
• acutely ill
• chronic disease

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Baylor College of Medicine: collaborator
• Kamuzu University of Health Sciences: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Unknown Facility

Limela, Malawi

Location

MeSH Terms

Conditions

Sprue, Tropical

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Mark Manary
• Organization: Washington University School of Medicine in St. Louis

manary@kids.wustl.edu

314 454-2178

Study Officials

• Mark J Manary

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-11

Locations

MA (1)