Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

Tanta University

Status

Not yet enrolling

Conditions

Ulcerative Colitis

Treatments

Drug: Mebendazole

Study type

Interventional

Funder types

Other

Identifiers

NCT06335160

Mebendazole Ulcerative Colitis

Details and patient eligibility

About

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

Full description

A randomized, controlled, and parallel study will comprise 46 patients with UC. Patients will be recruited from GastroEnterology Department, Mansoura University Hospital.

The participants will be randomly assigned into two groups as follow:

Group 1: control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.

Group 2: (mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.