Mebendazole added to mesalamine for adults with ulcerative colitis
Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
This will try adding mebendazole to standard mesalamine treatment to see if it helps control symptoms and is safe for adults with mild to moderate ulcerative colitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06335160 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled, parallel trial enrolling 46 adults with mild-to-moderate ulcerative colitis who are already on mesalamine. Participants are randomly assigned 1:1 to continue mesalamine alone or to receive mesalamine plus mebendazole 500 mg twice daily for six months. The study monitors safety and clinical response over the treatment period with regular clinic visits at the sponsoring university hospital. Patients with severe disease, major comorbidities, or concurrent immunosuppressive therapies are excluded.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed mild-to-moderate ulcerative colitis who are being treated with oral mesalamine and meet the study's health criteria are ideal candidates.
Not a fit: Patients with severe UC, those on systemic steroids, immunosuppressants or biologics, or with significant liver/kidney disease, seizures, recent colectomy, or other major comorbidities are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding mebendazole could offer an inexpensive adjunct to mesalamine that reduces inflammation and improves symptom control in mild-to-moderate UC.
How similar studies have performed: This represents a relatively novel repurposing of mebendazole with limited clinical data in UC, although preclinical studies and small reports have suggested anti-inflammatory effects.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.