Trial of Rifaximin in the Treatment of Tropical Enteropathy

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00858988
• Collaborator: Baylor College of Medicine (Other), University of Malawi College of Medicine (Other), United States Department of Agriculture (USDA) (U.S. Fed)
• Enrollment: 147
• Location: 1
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site Per Month: 149.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tropical Enteropathy	Drug: Rifaximin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy
• Actual Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rifaximin	Drug: Rifaximin; 100mg of rifaxin for 7 consecutive days, twice daily
Placebo Comparator: Placebo	Drug: Placebo; twice daily for 7 consecutive days

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• live in single village

Exclusion Criteria:

• acutely malnourished

• acutely ill

• chronic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Limela		Malawi

Sponsors and Collaborators

• Washington University School of Medicine
• Baylor College of Medicine
• University of Malawi College of Medicine
• United States Department of Agriculture (USDA)

Investigators

• Principal Investigator: Mark J Manary, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00858988
• Other Study ID Numbers: MJM-rifaximin
• First Posted: Mar 10, 2009
• Last Update Posted: Nov 12, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Intestinal Diseases; Sprue, Tropical; Rifaximin

Study Results

Participant Flow

Arm/Group Title	Rifaximin	Placebo
Arm/Group Description	Allocated to rifaximin	Allocated to placebo
Period Title: Randomized and Allocation
STARTED	74	73
COMPLETED	74	73
NOT COMPLETED	0	0
Period Title: Randomized and Allocation
STARTED	74	73
COMPLETED	72	72
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Rifaximin	Placebo	Total
Arm/Group Description	Allocated to rifaximin	Allocated to placebo	Total of all reporting groups
Overall Participants	72	72	144
Age, Customized (Months) [Mean (Standard Deviation) ]
Age	47.6 (6.5)	46.8 (7.6)	47.2 (7.6)
Sex: Female, Male (Count of Participants)
Female	32 44.4%	29 40.3%	61 42.4%
Male	40 55.6%	43 59.7%	83 57.6%

Outcome Measures

1. Primary Outcome

Title	Difference in the Urinary L:M Ratio Before and After the Intervention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rifaximin	Placebo
Arm/Group Description	Allocated to rifaximin	Allocated to placebo
Measure Participants	72	72
Mean (Standard Deviation) [Ratio of lactulose-to-mannitol (L:M) exc]	-0.01 (0.12)	0.02 (0.16)

Adverse Events

Arm/Group Title	Rifaximin		Placebo
Arm/Group Description	Allocated to rifaximin		Allocated to placebo
All Cause Mortality
	Rifaximin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)
Serious Adverse Events
	Rifaximin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Rifaximin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.