Induction of Clinical Response Using Rifaximin in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo Comparator; Rifaximin
Intervention type(s): Drug; Drug
Intervention description(s): Matching oral placebo pills to be taken twice daily for a total of 8 weeks; Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks
Other intervention name(s): Xifaxan
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease; Crohn disease; Crohn's disease; Rifaximin