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

Last updated: March 27, 2024
Sponsor: Tanta University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Colic

Inflammatory Bowel Disease

Treatment

Mebendazole

Clinical Study ID

NCT06335160
Mebendazole Ulcerative Colitis
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old Both male and female will be included Mild and moderate UC patientsdiagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)

Exclusion

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, ischemicheart 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, enzymeinducers (phenytoin, carbamazepine) and inhibitors (valoproate) to avoid potentialpharmacodynamics and pharmacokinetic interactions.

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: Mebendazole
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
May 31, 2025

Study 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.