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Recruiting NCT06993974

Nitazoxanide in Patients With Ulcerative Colitis

Phase II Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mesalamine, Nitazoxanide.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.

Overview

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.

Interventions

  • Drug Mesalamine
    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.
  • Drug Nitazoxanide
    Nitazoxanide is an FDA-approved oral medication used to treat protozoal infections and is also effective against metronidazole-resistant Clostridium difficile colitis.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Alexandria University — Alexandria

Identifiers

NCT: NCT06993974 · 4444

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗