Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05567068

Collaborator

(none)

Enrollment

Arms

55.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double-blinded.

Primary Purpose:

Treatment

Official Title:

Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Sep 20, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Group This group will take mesalamine 1 g three times daily	Drug: Mesalamine Mesalamine
Active Comparator: Atorvastatin group This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.	Drug: Atorvastatin 80mg Atrovastatin 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 Drug: Mesalamine Mesalamine

Arm

Intervention/Treatment

Other: Control Group

This group will take mesalamine 1 g three times daily

Drug: Mesalamine

Mesalamine

Active Comparator: Atorvastatin group

This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.

Drug: Atorvastatin 80mg

Atrovastatin 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

Drug: Mesalamine

Mesalamine

Outcome Measures

Primary Outcome Measures

Improvement in health related quality of life [6 months]
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms

Secondary Outcome Measures

changes in serum and fecal inflammatory biomarkers [6 months]
The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Both males and females 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:

NCT05567068

Other Study ID Numbers:

3433

First Posted:

Oct 5, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Mesalamine

Atorvastatin

Study Results

No Results Posted as of Oct 18, 2022