terminated due to slow recruitment

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.

Inclusion Criteria:

• Age ≥18 years.
• Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
• CDAI score ≥200 and ≤400.

Exclusion Criteria:

• Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.
• Evidence of bowel obstruction.
• Females that are pregnant, breast-feeding or not using birth control and are sexually active.
• Serious systemic disorders incompatible with the study.
• History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
• Uncontrolled gastro-intestinal bleeding.
• Evidence of intestinal abscess, non-perianal fistula or stricture.
• Patients who have received antibiotics in the past 7 days.
• Patients receiving >20 mg of prednisone, or its equivalent.
• Patients receiving Anucort-HC or rectal steroids.
• Patients receiving immunosuppressive therapy that has not been stabilized.
• Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.
• Patients with Crohn's disease confined to the esophagus, stomach and small bowel.