Clinical trial NCT06652464: Maresin-1 and Resolvin-D1 Levels and Disease Activity in Ulcerative Colitis
Official title: The Relationship Between Maresin-1 and Resolvin-D1 Levels and Disease Activity in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease Activity
Remission of Ulcerative Colitis
Ulcerative Colitis Flare
Keywords: maresin-1
resolvin-D1
ulcerative colitis
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active and remission phase ulcerative colitis and those in the control group who presented to the gastroenterology outpatient clinic of our hospital.

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.

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.

Primary outcomes:
measure: İnflammatory markers
timeFrame: Up to 2 months
Secondary outcomes:
measure: İnflammatory markers
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology and Training Research Hospital
Study officials:
affiliation: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
name: selim demirci, medical doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276.
citation: 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.
citation: 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.