Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
NCT ID: NCT06335160
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2024-04-20
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
No interventions assigned to this group
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
Mebendazole
mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months
Interventions
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Mebendazole
mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Eman Elberri
Lecturer
Locations
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Tanta Unuversity
Tanta, , Egypt
Countries
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Facility Contacts
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References
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Tolomeo M, Colomba C, Meli M, Cascio A. Hepatotoxicity caused by mebendazole in a patient with Gilbert's syndrome. J Clin Pharm Ther. 2019 Dec;44(6):985-987. doi: 10.1111/jcpt.13033. Epub 2019 Aug 18.
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.
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.
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.
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.
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.
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.
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.
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.
Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, Bernstein CN, Danese S, Peyrin-Biroulet L, Hibi T. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74. doi: 10.1038/s41572-020-0205-x.
Puente S, Lago M, Subirats M, Sanz-Esteban I, Arsuaga M, Vicente B, Alonso-Sardon M, Belhassen-Garcia M, Muro A. Imported Mansonella perstans infection in Spain. Infect Dis Poverty. 2020 Jul 23;9(1):105. doi: 10.1186/s40249-020-00729-9.
Sturm A, Maaser C, Calabrese E, Annese V, Fiorino G, Kucharzik T, Vavricka SR, Verstockt B, van Rheenen P, Tolan D, Taylor SA, Rimola J, Rieder F, Limdi JK, Laghi A, Krustins E, Kotze PG, Kopylov U, Katsanos K, Halligan S, Gordon H, Gonzalez Lama Y, Ellul P, Eliakim R, Castiglione F, Burisch J, Borralho Nunes P, Bettenworth D, Baumgart DC, Stoker J; European Crohn's and Colitis Organisation [ECCO] and the European Society of Gastrointestinal and Abdominal Radiology [ESGAR]. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects. J Crohns Colitis. 2019 Mar 26;13(3):273-284. doi: 10.1093/ecco-jcc/jjy114. No abstract available.
Wildenberg ME, Levin AD, Ceroni A, Guo Z, Koelink PJ, Hakvoort TBM, Westera L, Bloemendaal FM, Brandse JF, Simmons A, D'Haens GR, Ebner D, van den Brink GR. Benzimidazoles Promote Anti-TNF Mediated Induction of Regulatory Macrophages and Enhance Therapeutic Efficacy in a Murine Model. J Crohns Colitis. 2017 Dec 4;11(12):1480-1490. doi: 10.1093/ecco-jcc/jjx104.
Younis NS, Ghanim AMH, Saber S. Mebendazole augments sensitivity to sorafenib by targeting MAPK and BCL-2 signalling in n-nitrosodiethylamine-induced murine hepatocellular carcinoma. Sci Rep. 2019 Dec 13;9(1):19095. doi: 10.1038/s41598-019-55666-x.
Zingarelli B, Szabo C, Salzman AL. Reduced oxidative and nitrosative damage in murine experimental colitis in the absence of inducible nitric oxide synthase. Gut. 1999 Aug;45(2):199-209. doi: 10.1136/gut.45.2.199.
Other Identifiers
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Mebendazole Ulcerative Colitis
Identifier Type: -
Identifier Source: org_study_id
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