FindTrial
Sign In

Nitazoxanide in Patients With Ulcerative Colitis

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06993974
Enrollment
70
Registered
2025-05-29
Start date
2025-05-30
Completion date
2026-12-20
Last updated
2025-06-27

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

Conditions

Ulcerative Colitis

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.

Interventions

DRUGMesalamine

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.

DRUGNitazoxanide

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

Sponsors

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

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
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in partial mayo score.3 monthsOne 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026