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Completed

NCT Number: NCT06652464

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. İnflammatory markers

    Time frame: Up to 2 months

    Maresin-1 and Resolvin-D1 levels in study groups

Secondary outcomes

  1. İnflammatory markers

    Time frame: Up to 2 months

    White blood cell and CRP levels in study groups.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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