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

To investigate therapeutic potency of Mebendazole in decreasing ulcerative colitis clinical symptoms

This is a phase III randomized, parallel, double blinded, clinical trial with 54 participants divided into Standard versus Mebendazole-treated groups.

This is a clinical study on Therapeutic potency of Mebendazole in Ulcerative colitis which will be performed in Mashhad University of Medical Sciences Hospitals This is a double-blinded study in which both participants and data collectors will be blind to the study.

Inclusion criteria: 1. Informed consent 2. 18 to 60 years. 3. Moderate proctosigmoiditis and Left-sided colitis. 4. With no active gastrointestinal infection. Exclusion Criteria: 1. Subjects with Crohn's disease or other types of colitis including Infectious, Radiation or Ischemic colitis. 2. Allergy to Mesalamine or Mebendazole. 3. Subjects who have a positive pregnancy test, or breast feeding. 4. Subjects treated with immuno-modulatory drugs from two months before screening or receiving pro- or antibiotics from two weeks from screening. 5. Patients who have already received metronidazole or Mebendazole for parasitic worm infection. 6. patients with leukopenia, thrombocytopenia, neutropenia or Hb< 10. 7. Subjects with Chronic Medical Conditions including heart diseases, lung diseases esp. Tuberculosis, Renal dysfunction, liver diseases, coagulation disorders, Drug abuse 8. Patients with Ulcerative Proctitis.

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

Clinical Symptoms including weight loss, fever, bowel movement frequency, Stool consistency, Presence or absence of blood in feces, Mucus in feces will be investigated.

It is a Block randomized trial in which the Random Allocation Software will be used for allocation concealment which is performed according to SNOSE (sequentially numbered, opaque, sealed envelopes) technique. Envelopes will be sealed and one of the executive member will put randomized number into pockets . Following providing written documentation of informed consent to participate the subjects will pick up a pocket which will be divided into control or intervention group accordingly. Size of Blocks will be four in the study.

This is a double-blind clinical trial in which participants and data analyzers will be blinded to the study. In this randomized controlled trial blinding is achieved with placebo. Compared to the treatment, plecebo will have the same shape and color. Since double-blinded studies are considered valid approach in decreasing bias in clinical trials, both participants and data analyzers are blinded in this study. It is worth mentioning that participants are aware that they might be randomly categorized either in the treatment or control group. The principal investigator is responsible for the safety of the project, assessing results, and writing the manuscript. He is not blinded to final outcomes. Data collectors, Data analyzers will be blinded in this study. Data Safety and Monitoring Board are not blind to data.

We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study.

Sharing of all collected de-identified participants data (IPD) will be started immediately after publication.

All collected de-identified participants data (IPD) will be shared to people working either in academic institutions or business companies upon their request.

The collected de-identified participants data (IPD) will be only shared to those recipients who commit themselves to use them only for patients. They also should commit themselves to share these data with other organization only after asking permission from the original source.

Data/Documents will be obtainable by sending an e-mail to hasanianmehrm@mums.ac.ir

The applicant who wish to have access to document/data files should send an e-mail to hasanianmehrm@mums.ac.ir commit him/herself to not to share these documents with others unless asking permission from the original source. Next, document/data will be sent to him/her by e-mail immediately.