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

February 4, 2026 updated by: Eman Elberri, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
Active Comparator: 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
Drug: Mebendazole
mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change in baseline
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 baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Concentration
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
Blood samples will be taken from all patients at baseline then six months of therapy
Change in Erythrocyte sedimentation rate (ESR)
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum albumin
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Interleukin -6 (IL-6)
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Nitric oxide (NO)
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
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)
Time Frame: Blood samples will be taken from all patients at baseline then six months of therapy
Enzyme-linked immunosorbent assay (ELISA)
Blood samples will be taken from all patients at baseline then six months of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mebendazole Ulcerative Colitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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