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NCT Number: NCT06993974

Nitazoxanide in Patients With Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel Disease (IBD) that primarily affects the rectum and colon. The severity and persistence of mucosal inflammation are associated with morbidity and mortality.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alexandria University

Alexandria, Egypt

Location status: Recruiting

Location contact

Reham Elshafiey, PhD

CONTACT

[email protected]

01025465180

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Both male and female will be included
  • Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.

Exclusion criteria

  • Breast feeding or pregnancy.
  • Colorectal cancer patients.
  • Patients with severe UC.
  • Patients taking rectal or systemic steroids.
  • Patients taking immunosuppressives or biological therapies.
  • Addiction to alcohol and / or drugs.
  • Known allergy to the studied medications.

Treatment and study plan

Mesalamine

Drug

Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.

Nitazoxanide

Drug

Nitazoxanide is an FDA-approved oral medication used to treat protozoal infections and is also effective against metronidazole-resistant Clostridium difficile colitis.

Primary outcomes

  1. change in partial mayo score.

    Time frame: 3 months

    One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University.
  • Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.
  • Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.

Registry information

Official study title

Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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