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About
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.
Full 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.
Enrollment
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Inclusion criteria
Male or female subjects, 18 to 80 years of age, inclusive, that can themselves provide written, informed consent and authorization of use of protected health information prior to any study-related procedures and who are, in the opinion of the investigator(s), likely to comply with all the requirements of the study
Subjects must have a prior diagnosis of CD established by endoscopy and clinical parameters as determined by the investigator(s) for at least 3 months prior to randomization
Subjects must be able to participate in all required follow-up visits and fill out all related documentation (e.g. symptom diary)
Subjects currently with moderately active disease defined as a CDAI 250-450
Concomitant medications:
If subjects are at increased risk of colorectal cancer (defined as having an 8-year history of pan-colitis or 12 year history of left sided colitis), they will need to have undergone a colonoscopy with pan-colonic surveillance biopsies within 2 years of the screening visit. The biopsies must be negative for dysplasia
Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the screening visit through 30 days (females) and 30 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study
Exclusion criteria
Evidence of active infection which may include any of the following
Subjects with CDAI > 450
Any current use or use within the last 8 weeks of an investigational drug
Current or past use (within past 12 wks) of biological treatment
Current or use within the last 4 weeks of any oral or intravenous antibiotic
Anticipated increased dosage of any medication to treat CD
Anticipated need for surgery within 12 weeks
Known obstructive diseases of the gastrointestinal system
Medical conditions requiring in-patient hospitalization
Proctocolectomy, total colectomy, ileostomy, or stoma
Severe cardiopulmonary disease:
Significant liver disease:
Renal insufficiency, defined as serum creatinine > 150% of the upper limit of the normal range for the laboratory performing the test
Abnormal hematology parameters defined as severe anemia with hemoglobin < 8.5 g/dL and/or white blood cell count of < 3,500/ul
Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
History of dysplasia or carcinoma of the colon
Pregnant, lactating, or planning to become pregnant during the course of the investigational study
Known history of allergic reaction to rifaximin or allergy to any of the rifamycin antimicrobial agents (which include rifampin, rifabutin, and rifapentine)
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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