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Induction of Clinical Response Using Rifaximin in Crohn's Disease

NCT00603616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-12-09

No results posted yet for this study

Summary

Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces.

The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.

Conditions

Interventions

DRUG

Placebo Comparator

Matching oral placebo pills to be taken twice daily for a total of 8 weeks

DRUG

Rifaximin

Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Scott Lee

    lead OTHER

Principal Investigators

  • Scott D Lee, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2020-11-03
Completion
2020-11-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603616 on ClinicalTrials.gov