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Recruiting NCT06335160

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

No phase Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mebendazole.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • change in disease activity [Time frame: change in baseline]
  • change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity [Time frame: change in baseline]
Secondary outcome measures (6)
  • Change in Hemoglobin Concentration [Time frame: 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]
  • Change in Serum albumin [Time frame: 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]
  • Change in Serum Nitric oxide (NO) [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta Unuversity — Tanta

Publications

  • Andersson CR, Selvin T, Blom K, Rubin J, Berglund M, Jarvius M, Lenhammar L, Parrow V, Loskog A, Fryknas M, Nygren P, Larsson R. Mebendazole is unique among tubulin-active drugs in activating the MEK-ERK pathway. Sci Rep. 2020 Aug 4;10(1):13124. doi: 10.1038/s41598-020-68986-0. PMID 32753665
  • Elayapillai S, Ramraj S, Benbrook DM, Bieniasz M, Wang L, Pathuri G, Isingizwe ZR, Kennedy AL, Zhao YD, Lightfoot S, Hunsucker LA, Gunderson CC. Potential and mechanism of mebendazole for treatment and maintenance of ovarian cancer. Gynecol Oncol. 2021 Jan;160(1):302-311. doi: 10.1016/j.ygyno.2020.10.010. Epub 2020 Oct 31. PMID 33131904
  • Eskandari M, Asgharzadeh F, Askarnia-Faal MM, Naimi H, Avan A, Ahadi M, Vossoughinia H, Gharib M, Soleimani A, Naghibzadeh N, Ferns G, Ryzhikov M, Khazaei M, Hassanian SM. Mebendazole, an anti-helminth drug, suppresses inflammation, oxidative stress and injury in a mouse model of ulcerative colitis. Sci Rep. 2022 Jun 17;12(1):10249. doi: 10.1038/s41598-022-14420-6. PMID 35715495
  • Ford AC, Achkar JP, Khan KJ, Kane SV, Talley NJ, Marshall JK, Moayyedi P. Efficacy of 5-aminosalicylates in ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):601-16. doi: 10.1038/ajg.2011.67. Epub 2011 Mar 15. PMID 21407188
  • Guerini AE, Triggiani L, Maddalo M, Bonu ML, Frassine F, Baiguini A, Alghisi A, Tomasini D, Borghetti P, Pasinetti N, Bresciani R, Magrini SM, Buglione M. Mebendazole as a Candidate for Drug Repurposing in Oncology: An Extensive Review of Current Literature. Cancers (Basel). 2019 Aug 31;11(9):1284. doi: 10.3390/cancers11091284. PMID 31480477
  • Hegazy SK, El-Azab GA, Zakaria F, Mostafa MF, El-Ghoneimy RA. Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer. Life Sci. 2022 Jun 15;299:120536. doi: 10.1016/j.lfs.2022.120536. Epub 2022 Apr 3. PMID 35385794
  • Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8. PMID 8759664
  • Jena G, Trivedi PP, Sandala B. Oxidative stress in ulcerative colitis: an old concept but a new concern. Free Radic Res. 2012 Nov;46(11):1339-45. doi: 10.3109/10715762.2012.717692. Epub 2012 Sep 5. PMID 22856328

Identifiers

NCT: NCT06335160 · Mebendazole Ulcerative Colitis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗