Nitazoxanide in Patients With Ulcerative Colitis

Alexandria University

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalamine; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT06993974

4444

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Control group

Active Comparator group

Description:

Control group, n =35: who will receive 1 g mesalamine three times daily for 3 months.

Treatment:

Drug: Mesalamine

Nitazoxanide group

Active Comparator group

Description:

Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.

Treatment:

Drug: Nitazoxanide

Drug: Mesalamine