Nitazoxanide in Patients With Ulcerative Colitis
- Registration Number
- NCT06993974
- Lead Sponsor
- Alexandria University
- Brief Summary
Ulcerative colitis (UC) is a chronic inflammatory bowel Disease (IBD) that primarily affects the rectum and colon. The severity and persistence of mucosal inflammation are associated with morbidity and mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Age ≥ 18 years
- Both male and female will be included
- Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.
Exclusion Criteria
- Breast feeding or pregnancy.
- Colorectal cancer patients.
- Patients with severe UC.
- Patients taking rectal or systemic steroids.
- Patients taking immunosuppressives or biological therapies.
- Addiction to alcohol and / or drugs.
- Known allergy to the studied medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Mesalamine Control group, n =35: who will receive 1 g mesalamine three times daily for 3 months. Nitazoxanide group Mesalamine Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months. Nitazoxanide group Nitazoxanide Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.
- Primary Outcome Measures
Name Time Method change in partial mayo score. 3 months One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alexandria University
🇪🇬Alexandria, Egypt
Alexandria University🇪🇬Alexandria, Egypt