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Mebendazole in combination with mesalamine against Ulcerative colitis

To investigate the therapeutic potency of Mebendazole in combination with standard treatment, mesalamine, in Ulcerative colitis patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220115053713N2
Enrollment
54
Registered
2022-04-16
Start date
2022-04-21
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Ulcerative (chronic) rectosigmoiditis. Condition 2: Left sided colitis, left hemicolitis. Ulcerative (chronic) rectosigmoiditis Left sided colitis

Interventions

Intervention 1: Intervention group: Ulcerative colitis patients in the intervention group will receive Mesalazine as standard treatment (3g/daily) combined with 300 mg/daily of Mebendazole orally. Int

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Provide written documentation of informed consent to participate in the study. Male or female aged 18 to 60 years. Subjects with a confirmed diagnosis of moderate proctosigmoiditis and Left-sided colitis. Diagnosis established by endoscopy and histology. Participants have no proven current active gastrointestinal infection.

Exclusion criteria

Exclusion criteria: Subjects with Crohn's disease or other types of colitis including Infectious, Radiation or Ischemic colitis. Allergy to Mesalamine or Mebendazole. Subjects who have a positive pregnancy test, or breast feeding. Subjects treated with immuno-modulatory drugs from two months before screening or receiving pro- or antibiotics from two weeks from screening. Patients who have already received metronidazole or Mebendazole for parasitic worm infection. Subjects with leukopenia, thrombocytopenia, neutropenia, Hb< 10 Subjects with Chronic Medical Conditions including heart diseases, lung diseases esp. Tuberculosis, Renal dysfunction, liver diseases, coagulation disorders, Drug abuse Patients with Ulcerative Proctitis.

Design outcomes

Primary

MeasureTime frame
Clinical Symptoms including weight loss, fever, bowel movement frequency, Stool consistency, Presence or absence of blood in feces, Mucus in feces. Timepoint: Before intervention, 1, 2 and 3 months after intervention. Method of measurement: Will be evaluated by physician.

Secondary

MeasureTime frame
Laboratory Findings including measurement of Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, total and direct bilirubin, albumin, urea, creatinine, sodium, potassium, complete blood count, prothrombin time, partial thromboplastin time, international normalized ratio, total iron-binding capacity, iron, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin, and stool culture. Timepoint: Before intervention, 1, 2 and 3 months after intervention. Method of measurement: Standard laboratory methods.;Histological findings including functional and cytological changes in crypts, presence of Paneth cells, alterations in mucus and sub-mucus, presence of crypt abscess, Cryptitis, reduction in intraepithelial muscins, presence of eosinophils in lamina propria, Basal Plasmacytosis and basal lymphoid aggregates. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Histology.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mahdi Hassanian Mehr

Mashhad University of Medical Sciences

hasanianmehrm@mums.ac.ir+98 51 3800 2353

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026