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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | May 30, 2025 |
| Main results expected | August 20, 2026 |
| Study ends | December 20, 2026 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT06993974 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.