Nitazoxanide as an add-on therapy for mild-to-moderate ulcerative colitis
Official title: Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Run by Tanta University · NCT07820046 · Data updated 2026-11-12
A study tests whether adding nitazoxanide to standard UC treatment helps people with mild-to-moderate ulcerative colitis see more relief.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta and 1 other locations) |
| Status | Recruiting |
| Started | October 25, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07820046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with confirmed ulcerative colitis for at least 6 months and active mild-to-moderate disease (Mayo 3-10) on stable therapy.
✕Probably not a fit
Patients with severe/fulminant UC, recent antibiotic or biologic changes, or significant comorbidities may not benefit from this adjunct therapy.
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 randomized, double-blind, placebo-controlled trial that compares nitazoxanide alongside standard UC therapy to placebo over 12 weeks in adults with mild-to-moderate UC. Participants must have stable UC treatment and active disease within Mayo 3-10. The goal is to see if nitazoxanide improves symptoms and maintains safety when used as an adjunct. The study explores nitazoxanide’s potential to improve intestinal barrier function, reduce inflammation, and modulate immune responses in UC. Results could inform whether adding nitazoxanide offers a meaningful benefit beyond current therapies.
Why it matters
Potential benefit: If successful, participants may experience better symptom control and disease management when nitazoxanide is added to their current treatment.
How similar studies have gone: Preclinical and early data suggest potential benefit, but robust clinical evidence in UC is limited and this trial aims to provide clearer efficacy and safety data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age 18-65 years * Confirmed ulcerative colitis ≥ 6 months * Mild-to-moderate active disease (Mayo score 3-10) * Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria * Severe/fulminant UC requiring hospitalization or surgery * Active intestinal infection (e.g., C. difficile) * Antibiotics/probiotics/investigational drugs within 4 weeks * Recent biologic initiation or dose change * Severe hepatic, renal, cardiovascular disease, or malignancy * Pregnancy or lactation * Known hypersensitivity to nitazoxanide
Where it's running
-
Tanta university hospital
Tanta, Egypt Recruiting -
Tanta University Hospital
Tanta, Egypt Recruiting
Study contacts
- Study coordinator: Khadija Glal
- Email: khadija.ahmed@pharm.tanta.edu.eg
- Phone: +201118969649
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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.