NCT06652464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

October 15, 2024

Last Update Submit

March 5, 2025

Conditions

Keywords

maresin-1resolvin-D1ulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • İnflammatory markers

    Maresin-1 and Resolvin-D1 levels in study groups

    Up to 2 months

Secondary Outcomes (1)

  • İnflammatory markers

    Up to 2 months

Study Arms (3)

Active

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

Remission

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

Control

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (3)

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

    PMID: 16369558BACKGROUND
  • 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.

    PMID: 24656045BACKGROUND
  • 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.

    PMID: 19103881BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • selim demirci, medical doctor

    Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 22, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 15, 2024

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations