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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• change in disease activity [Срок оценки: change in baseline]
• change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity [Срок оценки: change in baseline]

Вторичные конечные точки (6)

• Change in Hemoglobin Concentration [Срок оценки: Blood samples will be taken from all patients at baseline then six months of therapy]
• Change in Erythrocyte sedimentation rate (ESR) [Срок оценки: Blood samples will be taken from all patients at baseline then six months of therapy]
• Change in Serum albumin [Срок оценки: Blood samples will be taken from all patients at baseline then six months of therapy]
• Change in Serum Interleukin -6 (IL-6) [Срок оценки: Blood samples will be taken from all patients at baseline then six months of therapy]
• Change in Serum Nitric oxide (NO) [Срок оценки: 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) [Срок оценки: Blood samples will be taken from all patients at baseline then six months of therapy]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• \- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Tanta Unuversity — Tanta

Публикации

• 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

Идентификаторы

NCT: NCT06335160 · Mebendazole Ulcerative Colitis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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