Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Group
Treatment group( mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months
Intervention: Mebendazole (Drug)
Control Group
control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
Outcomes
Primary Outcomes
change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Serum Interleukin -6 (IL-6)(Blood samples will be taken from all patients at baseline then six months of therapy)
- Change in Serum Nitric oxide (NO)(Blood samples will be taken from all patients at baseline then six months of therapy)
- Change in Hemoglobin Concentration(Blood samples will be taken from all patients at baseline then six months of therapy)
- 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)
- Change in Erythrocyte sedimentation rate (ESR)(Blood samples will be taken from all patients at baseline then six months of therapy)
- Change in Serum albumin(Blood samples will be taken from all patients at baseline then six months of therapy)
Investigators
Eman Elberri
Lecturer
Tanta University