Trial of Rifaximin in the Treatment of Tropical Enteropathy

NCT ID: NCT00858988

Last Updated: 2019-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tropical Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifaximin

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

100mg of rifaxin for 7 consecutive days, twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice daily for 7 consecutive days

Interventions

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Rifaximin

100mg of rifaxin for 7 consecutive days, twice daily

Intervention Type DRUG

Placebo

twice daily for 7 consecutive days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* live in single village

Exclusion Criteria

* acutely malnourished
* acutely ill
* chronic disease
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Limela, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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MJM-rifaximin

Identifier Type: -

Identifier Source: org_study_id

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