The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.
There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
One nitazoxanide 500 mg tablet twice daily for 28 days
One placebo tablet twice daily for 28 days
Romark Laboratories, L.C.
Tampa, Florida, United States
Florida medical Clinic, P.A.
Zephyrhills, Florida, United States
Atlanta Gastroenterology
Marietta, Georgia, United States
Change in Crohn's Disease Activity Index (CDAI)
Time frame: Day 14
Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels
Time frame: Days 14 and 28
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Atlanta Gastroenterology
Woodstock, Georgia, United States
Gasteroenterology Associates
Baton Rouge, Louisiana, United States
Minnesota Gastroenterology, P.A., Clinical Research Division
Plymouth, Minnesota, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Greater Cincinnati Gastroenterology Associates
Cincinnati, Ohio, United States
Digestive Research & Infusion Institute
Mayfield Heights, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
...and 3 more locations