Nitazoxanide in Patients With Ulcerative Colitis

NCT06993974 | Recruiting Phase 2

• 1 other identifier: 4444
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• change in partial mayo score.

  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

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group, n =35: who will receive 1 g mesalamine three times daily for 3 months.

Drug: Mesalamine

Nitazoxanide group

ACTIVE COMPARATOR

Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.

Drug: Mesalamine; Drug: Nitazoxanide

Interventions

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.

Control group; Nitazoxanide group

Nitazoxanide DRUG

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

Nitazoxanide group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; nitazoxanide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

EG (1)