Mebendazole in combination with mesalamine against Ulcerative colitis

Phase 3

Recruiting

Conditions: Condition 1: Ulcerative (chronic) rectosigmoiditis. Condition 2: Left sided colitis, left hemicolitis.
Ulcerative (chronic) rectosigmoiditis
Left sided colitis
K51.3
K51.5

Registration Number: IRCT20220115053713N2

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 54

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
aboratory 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.