Clinical trial Recruiting at 2 sites Phase2; Phase3 Interventional Ages 18 to 65

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.

More Ulcerative Colitis (UC) trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment44 (estimated)
SponsorTanta University
Academic / other
Locations2 sites (Tanta and 1 other locations)
StatusRecruiting
StartedOctober 25, 2026
Main results expectedJune 1, 2027
Study endsJune 1, 2027
Registry record updatedNovember 9, 2026
Trial IDNCT07820046 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

Similar studies

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

  • MGT-006 safety and dosing study for ulcerative colitis

    This study tests an oral microbiome capsule called MGT-006 to see if it is safe and tolerable in adults with moderately active ulcerative colitis, and whether the gut bacteria engraft after treatment.

    Recruiting at 9 sites Phase 1/2 Metagen Therapeutics, Inc. · Naples, Florida and 11 other locations · NCT07913347

  • PALI-2108 vs placebo for moderate to severe ulcerative colitis

    A phase 2 study to see if PALI-2108 helps people with moderate to severe ulcerative colitis more than a placebo.

    Recruiting at 28 sites Phase 2 Palisade Bio · Sun City, Arizona and 114 other locations · NCT07845487

  • Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis

    This study tests whether fecal microbiota transplantation from healthy Dai donors improves symptoms in adults with ulcerative colitis more than transplantation from healthy Han donors.

    Recruiting Phase 2 First Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07814456

  • Familial IBD Early Risk

    This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.

    Recruiting Seattle Children's Hospital · Seattle, Washington · NCT07791862

  • Probiotics and Trace Elements Added to Infliximab in Ulcerative Colitis

    This trial tests whether adding a Lactobacillus probiotic or trace elements to infliximab helps people with ulcerative colitis stay in remission.

    Recruiting Phase 4 National Hepatology & Tropical Medicine Research Institute · Cairo · NCT07758335

  • AC-101 tablets in ulcerative colitis: a dose-finding study

    This phase 2b trial tests AC-101 tablets versus placebo in adults with moderately to severely active ulcerative colitis who have not had adequate benefit from prior therapies.

    Recruiting Phase 2 Accro Bioscience (Suzhou) Limited · Guangzhou, Guangdong · NCT07755241

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.