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NCT Number: NCT06335160

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mebendazole

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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