Maresin-1 and Resolvin-D1 Levels and Disease Activity in Ulcerative Colitis

NCT ID: NCT06652464

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-11-15

Brief Summary

Specialized pro-resolving mediators (SPMs), which are typically thought to be formed via consecutive steps of oxidation of polyenoic fatty acids, have been shown to suppress inflammation and promote timely resolution of inflammation. They are mainly divided into four categories: lipoxins, resolvins, protectins, and maresins. The study will compare Maresin-1 and Resolvin-D1 levels in ulcerative colitis patients with those in the control group.

Detailed Description

Ulcerative colitis is a chronic inflammatory bowel disease characterized by inflammation of the superficial colonic mucosa, which starts in the rectum and diffusely extends throughout the colon, with alternating periods of flare-ups and remission. The diagnosis, activity, and treatment outcomes of ulcerative colitis are evaluated through a combination of symptoms, clinical examination, laboratory tests, radiology, endoscopy, and histological findings. Assessing inflammatory activity is crucial for approaching the disease and shaping treatment. Therefore, studies have aimed to identify the ideal disease marker. In recent years, there has been a search for non-invasive, easy, and quick laboratory markers to evaluate disease activity and treatment response. The optimal marker should be disease-specific, accurately reflect disease activity, be easily applicable in clinical practice, and identify patients at risk of relapse. Many clinical activity indicators and non-invasive markers have been used for this purpose, but they have only provided indirect findings in assessing disease activity.

When the impact of inflammation reaches a certain stage, a number of endogenous pro-resolving lipid mediators are synthesized to promote the resolution of inflammation. These mediators remove pro-inflammatory mediators and inflammatory cells from the site, repair damaged tissues, and eventually terminate inflammatory responses. If they cannot be produced at adequate levels and/or fail to function properly, inflammation cannot resolve during this process, leading to a chronic inflammatory phase. Several endogenous pro-resolving lipid mediators such as maresins, lipoxins, protectins, and resolvins have been discovered in recent years through scientific research. Many studies in the literature indicate that these mediators maintain a balance of pro-inflammatory chemical mediators, reduce the tissue infiltration of PMNLs (polymorphonuclear leukocytes), enhance macrophage efferocytosis and phagocytosis, and decrease collateral tissue damage caused by phagocytic cells.

Maresin-1 and resolvin-D1 are lipid molecules synthesized in macrophages and are produced from omega-3 polyunsaturated fatty acid, docosahexaenoic acid (DHA), and have been identified as a novel type of inflammatory mediator. Multiple studies have shown that Maresin-1 can control the inflammatory response by inhibiting neutrophil infiltration, downregulating the production of pro-inflammatory mediators, inhibiting NF-κB activation, restoring the Treg/Th17 balance, and alleviating endoplasmic reticulum stress.

Resolvin-D1 and Maresin-1 exhibit anti-inflammatory activity.The study aims to compare the serum levels of Resolvin-D1 (RvD1) and Maresin-1 (Mar1) during remission and active phases of ulcerative colitis with those in a control group, to evaluate whether they correlate with clinical and laboratory features, and to determine their potential use as markers reflecting inflammation in the diagnosis of ulcerative colitis.

Conditions

Disease Activity; Remission of Ulcerative Colitis; Ulcerative Colitis Flare

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Active

Group of ulcerative colitis patients considered active according to the Mayo score. (30 patients)

No interventions assigned to this group

Remission

Group of ulcerative colitis patients considered remission according to the Mayo score. (30 patients)

No interventions assigned to this group

Control

Group without ulcerative colitis or inflammatory disease. (30 patients)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with ulcerative colitis in active and remission phases, and a control group without acute or chronic inflammatory disease.

Exclusion Criteria

• Active malignancy
• Chronic kidney disease
• Diabetes mellitus
• Collagen tissue disease
• History of colectomy
• Acute infection
• Pregnancy / lactation period
• Within the past week, history of omega-3 dietary supplementation, non-steroidal anti-inflammatory drug use, or fish consumption.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

selim demirci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

selim demirci, medical doctor

Role: PRINCIPAL_INVESTIGATOR

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Locations

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276.

Reference Type: BACKGROUND

PMID: 16369558 (View on PubMed)

Buckley CD, Gilroy DW, Serhan CN. Proresolving lipid mediators and mechanisms in the resolution of acute inflammation. Immunity. 2014 Mar 20;40(3):315-27. doi: 10.1016/j.immuni.2014.02.009.

Reference Type: BACKGROUND

PMID: 24656045 (View on PubMed)

Serhan CN, Yang R, Martinod K, Kasuga K, Pillai PS, Porter TF, Oh SF, Spite M. Maresins: novel macrophage mediators with potent antiinflammatory and proresolving actions. J Exp Med. 2009 Jan 16;206(1):15-23. doi: 10.1084/jem.20081880. Epub 2008 Dec 22.

Reference Type: BACKGROUND

PMID: 19103881 (View on PubMed)

Other Identifiers

2024 - 01/07

Identifier Type: -

Identifier Source: org_study_id