Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis

Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07820046

Enrollment

Registered

2026-09-15

Start date

2027-01-01

Completion date

2028-01-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Brief summary

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. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis. Nitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited. This randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.

Interventions

DRUGNitazoxanide (NTZ)

Nitazoxanide 500 mg orally twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)	12 weeks	Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis). The Mayo Score ranges from 0 to 12, with higher scores indicating worse disease activity. Therefore, a decrease in score represents clinical improvement.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026