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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nitazoxanide (NTZ)

    Drug

    Nitazoxanide 500 mg orally twice daily

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Arm 1Placebo comparator 1 intervention
Group B: Arm 2:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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