Nitazoxanide in Patients With Ulcerative Colitis

Sponsor
Alexandria University
Study ID
NCT06993974
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesalamine — DRUG
    Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.
  • Nitazoxanide — DRUG
    Nitazoxanide is an FDA-approved oral medication used to treat protozoal infections and is also effective against metronidazole-resistant Clostridium difficile colitis.

Study Details

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.

Key Dates

First listed
May 29, 2025
Start date
May 30, 2025
Status verified
Jun 2025
Primary completion
Aug 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

change in partial mayo score. [ Time Frame: 3 months ]

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