Induction of Clinical Response Using Rifaximin in Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Prospective, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of Rifaximin for the Treatment of Moderate to Severe Crohn's Disease|
- Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of rifaximin compared to placebo at inducing clinical remission in CD subjects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Evaluate the safety profile of rifaximin in subjects with active CD [ Time Frame: 16 weeks for those subjects who do not cross over, 32 weeks for those who do cross over ] [ Designated as safety issue: Yes ]
- Evaluate the effect rifaximin has on the quality of life in subjects with CD compared to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Evaluate if there are any clinical parameters which might predict response to rifaximin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Compare mean changes in CDAI scores between rifaximin and placebo treated subjects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Drug: Placebo Comparator
Matching oral placebo pills to be taken twice daily for a total of 8 weeks
Active Comparator: 2
Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks
Other Name: Xifaxan
Inflammatory bowel disease (IBD) is a debilitating chronic inflammatory disease conventionally categorized into Crohn's disease (CD) and Ulcerative Colitis (UC). CD affects nearly 630,000 people in North America with up to 50,000 new people being diagnosed every year. It is a chronic debilitating disease characterized by abdominal pain, malnutrition, bloody diarrhea, fistula formation, intestinal perforations and strictures, and even extra-intestinal manifestations such as joint pains and skin rashes. Nearly 80% of people with CD will need surgical treatment at some point in their disease process. The majority of CD subjects are diagnosed in young adulthood thereby subjecting them to many decades of discomfort and medical intervention.
Antibiotics have been used to treat CD with variable response rates. The basis for antibiotic therapy is that breakdown of the integrity of the mucosal barrier in the gastrointestinal (GI) tract leads to a heightened inflammatory response to commensurate luminal bacteria. By changing the composition or bacterial load in the intestinal lumen, it may be possible to alter the immune response. Ciprofloxacin (Cipro) and metronidazole (Flagyl) are the best studied antibiotics that have shown efficacy, but the effect is temporal and long term use can lead to serious side effects. Rifaximin is a recent FDA approved antibiotic with broad spectrum of activity, excellent safety profile, and minimal absorption from the GI tract. Open label and small studies in IBD subjects show response rates up to 80% in CD subjects. These studies were limited however in that they were not randomized placebo controlled trials.
The investigators propose to conduct a randomized placebo controlled crossover trial of rifaximin in CD subjects to assess initial clinical response compared to placebo.
|Contact: Chelle Wheat, MPHfirstname.lastname@example.org|
|Contact: Elisa Beebe, BSemail@example.com|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Chelle Wheat, MPH 206-221-3338 firstname.lastname@example.org|
|Contact: Elisa Beebe, BS 206-543-3500 email@example.com|
|Principal Investigator: Scott D Lee, MD|
|Sub-Investigator: Michael Saunders, MD|
|Sub-Investigator: Ru Chen, PhD|
|Sub-Investigator: Joo Ha Hwang, MD|
|Principal Investigator:||Scott D Lee, MD||University of Washington|