Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Nitazoxanide with mesalamine for mild-to-moderate ulcerative colitis

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

Run by Alexandria University · NCT06993974 · Data updated 2026-11-12

This trial will test whether adding nitazoxanide to standard mesalamine helps adults with mild-to-moderate ulcerative colitis feel better and reduce gut inflammation.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment70 (estimated)
SponsorAlexandria University
Academic / other
Locations1 site (Alexandria)
StatusRecruiting
StartedMay 30, 2025
Main results expectedAugust 20, 2026
Study endsDecember 20, 2026
Registry record updatedJune 27, 2025
Trial IDNCT06993974 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with endoscopically and histologically confirmed mild-to-moderate ulcerative colitis who are not taking systemic or rectal steroids, immunosuppressives, or biologic therapies and who are not pregnant or breastfeeding.

Probably not a fit

Patients with severe ulcerative colitis, current steroid/immunosuppressive/biologic treatment, colorectal cancer, or those who are pregnant or breastfeeding are unlikely to be eligible or benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial enrolling adults with confirmed mild-to-moderate ulcerative colitis. Participants meeting eligibility will receive nitazoxanide in combination with mesalamine and be followed over the treatment period for changes in symptoms and objective markers of colonic inflammation. Exclusion criteria include severe UC, current systemic or rectal steroid use, immunosuppressive or biologic therapy, pregnancy or breastfeeding, and colorectal cancer. Clinical, endoscopic, and histologic measures will be used to judge whether the combination reduces mucosal inflammation compared with baseline.

Why it matters

Potential benefit: If successful, adding nitazoxanide could reduce colonic inflammation and symptoms, possibly improving mucosal healing and lowering flare risk.

How similar studies have gone: There is limited published clinical data on nitazoxanide for ulcerative colitis, so this repurposing approach is relatively novel with sparse prior evidence.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Alexandria University
    Alexandria, Egypt
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.