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

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mebendazole

• Registration Number: NCT06335160
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Study Start: 2024-04
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Mebendazole	Treatment group( mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months

Primary Outcome Measures

Name	Time	Method
change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity	change in baseline	depends on three items; stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.; Remission is defined as total PMSI = 0-1, mild disease is defined as total PMSI = 2-4, moderate disease is defined as total PMSI = 5-6 and severe disease is defined as total PMSI =7-9.
change in disease activity	change in baseline	Disease severity which will be assessed according to the modified Truelove and Witt's classification based on number of bloody stools per day plus one or more of 4 additional criteria including pulse, temperature, hemoglobin and Erythrocyte sedimentation rate (ESR) . Remission will be defined as disappearance or improvement of symptoms such as normal stool and stooling pattern without blood, no fever, no tachycardia, hemoglobin level normal or returning toward normal, ESR normal or returning toward normal, and patient gaining weight.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Interleukin -6 (IL-6)	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)
Change in Serum Nitric oxide (NO)	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)
Change in Hemoglobin Concentration	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)
Change in Serum Intra cellular adhesion molecule 1 (ICAM-1)	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)
Change in Erythrocyte sedimentation rate (ESR)	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)
Change in Serum albumin	Blood samples will be taken from all patients at baseline then six months of therapy	Enzyme-linked immunosorbent assay (ELISA)