Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis
Phase 2 / Phase 3 · Testing Nitazoxanide (NTZ) · Sites not listed yet · Tanta University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Nitazoxanide (NTZ) (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Age 18-65 years
- Confirmed ulcerative colitis ≥ 6 months
- Mild-to-moderate active disease (Mayo score 3-10)
Plus 8 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 44 participants are expected to take part.
- Start date: 2027-01-01 (planned).
- Main results expected around 2028-01-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis) (12 weeks)
In the researchers’ words
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Tanta University |
| Enrollment | 44 (estimated) |
| Start date | 2027-01-01 |
| Primary completion (est.) | 2028-01-01 |
| First posted | 2026-09-15 |
| Last updated | 2026-09-15 |
| Official title | Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial |
| ClinicalTrials.gov ID | NCT07820046 |
Interventions
- Nitazoxanide (NTZ) (Drug)
Nitazoxanide 500 mg orally twice daily
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.