Nitazoxanide with mesalamine for mild-to-moderate ulcerative colitis
Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.
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 |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06993974 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: There is limited published clinical data on nitazoxanide for ulcerative colitis, so this repurposing approach is relatively novel with sparse prior evidence.
Eligibility criteria
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 this trial is running
Alexandria
- Alexandria University — Alexandria, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.