Atorvastatin in Patients With Ulcerative Colitis

• Sponsor: Tanta University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05561062
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 54.6

Study Details

Study Description

Brief Summary

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Atorvastatin 80mg	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: double-blinded
• Primary Purpose: Treatment
• Official Title: Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Jun 20, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group This group will take 1 g mesalamine three times daily
Active Comparator: Atorvastatin group This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily	Drug: Atorvastatin 80mg; Atorvastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis. it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of its basic lipid-lowering properties

Outcome Measures

Primary Outcome Measures

1. Improvement in health related quality of life [6 months]

   HRQL questionnaire will be assessed according to a short-form (SF-36) questionnaire. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.

Secondary Outcome Measures

1. changes in the level of inflammatory biomarkers [6 months]

   changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years

• Both male and female will be included

• Negative pregnancy test and effective contraception

Exclusion Criteria:

• Breastfeeding

• Significant liver and kidney function abnormalities

• Colorectal cancer patients

• Patients with severe UC

• Patients taking rectal or systemic steroids

• Patients taking immunosuppressives or biological therapies

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mostafa Bahaa, Teaching Assistant, Tanta University
• ClinicalTrials.gov Identifier: NCT05561062
• Other Study ID Numbers: 9/22021
• First Posted: Sep 30, 2022
• Last Update Posted: Oct 18, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Atorvastatin

Study Results

No Results Posted as of Oct 18, 2022