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

NCT06335160 | Recruiting

• 1 other identifier: Mebendazole Ulcerative Colitis
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

MBZ, UC

Outcome Measures

Primary Outcomes (2)

• change in disease activity

  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

  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 Outcomes (6)

• Change in Hemoglobin Concentration

  Blood samples will be taken from all patients at baseline then six months of therapy

• Change in Erythrocyte sedimentation rate (ESR)

  Blood samples will be taken from all patients at baseline then six months of therapy

• Change in Serum albumin

  Blood samples will be taken from all patients at baseline then six months of therapy

• Change in Serum Interleukin -6 (IL-6)

  Blood samples will be taken from all patients at baseline then six months of therapy

• Change in Serum Nitric oxide (NO)

  Blood samples will be taken from all patients at baseline then six months of therapy

Study Arms (2)

Control Group

NO INTERVENTION

control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.

Treatment Group

ACTIVE COMPARATOR

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

Interventions

Mebendazole DRUG

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 34518, Egypt

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32913180 BACKGROUND

• 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.

  PMID: 32703283 BACKGROUND

• 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.

  PMID: 30137278 BACKGROUND

• 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.

  PMID: 31423600 BACKGROUND

• 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.

  PMID: 28961920 BACKGROUND

• 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.

  PMID: 31836811 BACKGROUND

• 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.

  PMID: 10403731 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: April 20, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

EG (1)