Clinical trial

Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

NCT06335160

Name

Mebendazole Ulcerative Colitis

Description

To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine

Trial arms

Trial start

2024-04-01

Estimated PCD

2025-04-01

Trial end

2025-05-01

Status

Not yet recruiting

Treatment

Mebendazole

mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months

Arms:

Treatment Group

Size

Primary endpoint

change in disease activity

change in baseline

change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity

change in baseline

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine) Exclusion Criteria: * - Patients with severe UC * Significant liver and kidney function abnormalities * Diabetic patients * Patients with Colorectal cancer patients * Patients taking rectal or systemic steroids * Patients on immunosuppressants or biological therapies * Addiction to alcohol and / or drugs * Known allergy to the studied medications * History of complete or partial colectomy. * Patients with congestive heart failure, other heart disease (arrhythmia, ischemic heart disease including angina and myocardial infarction). * Patients with other inflammatory diseases and active infection. * Patients with stressful condition (COPD, morbid obesity). * Patients with liver disease. * Patients with thrombocytopenia and neutropenia. * Patients with any type of seizures (case report for mebendazole induced convulsion). * Patients with renal disease (case report for mebendazole induced nephrotoxicity). * Patients with coagulation disorders. * Patients on metronidazole (to avoid Stevens-Johnson syndrome). * Patients with hypersensitivity to mebendazole, albendazole or benzimidazole * Patients using antioxidants. * Pregnant and lactating females. * Patients receiving, metronidazole, warfarin, low dose of aspirin, clopidogril, enzyme inducers (phenytoin, carbamazepine) and inhibitors (valoproate) to avoid potential pharmacodynamics and pharmacokinetic interactions.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

Updated at

2024-03-28

1 organization

1 product

1 indication

Organization

Tanta University

Product

Mebendazole

Indication

ulcerative colitis