Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

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.