The Diagnostic Value of Serum Oncostatin M and Galactin 3 as Biomarkers in Diagnosis of Ulcerative Colitis Disease

NCT06959654 | Not Yet Recruiting

• 1 other identifier: Soh-med-25-4-2MD
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inflammatory bowel diseases (IBD)-Crohn's disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBD-U)-are chronic inflammatory conditions that mainly affect the gastrointestinal tract but might also involve other organs, so they are considered systemic diseases. IBD is mainly diagnosed in young people, and is associated with significant morbidity and disability (Kaplan, 2015). Ulcerative colitis (UC) is an idiopathic, chronic inflammatory illness of the colon that is characterized by continous, diffuse mucosal inflammation (Ordás et al., 2012).

Conditions

Ulcerative Colitis Disease Patients and Normal Patients

Outcome Measures

Primary Outcomes (1)

• Assessment of Serum value of oncosatin M and galactin 3 patients with ulcerative colitis

  \- OSM and galactin 3 serum level measurement using the sandwich enzyme-linked immunosorbent test (ELISA), using a commercially available kit

  1year

Study Arms (2)

Group 1 :-normal healthy patients

ACTIVE COMPARATOR

The study group will include 40 normal healthy subject.

Diagnostic Test: ELISA test

Group2:-ulcerative colitis disease patients

ACTIVE COMPARATOR

The study group will include 50 patients newly diagnosed with confirmed ulcerative colitis who divided into active and non active.

Diagnostic Test: ELISA test

Interventions

ELISA test DIAGNOSTIC_TEST

ELISA test to evaulate serum oncostatin M and galactin 3 in two group of patientsL

Group 1 :-normal healthy patients; Group2:-ulcerative colitis disease patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients, both male and female, who are over the age of 18 and were identified as having ulcerative colitis based on histological, clinical, and endoscopic criteria.
• Group I The study group will include 40 normal healthy subject. Group II The study group will include 50 patients newly diagnosed with confirmed ulcerative colitis who divided into active and non active.
• Ulcerative colitis activity diagnosed by Simple Clinical Colitis Activity Index (SCCAI) is a diagnostic tool and questionnaire used to assess the severity of symptoms in people who suffer from ulcerative colitis(Walmsley et al.,1998). The calculated score ranges from 0 to20, where active disease is a score of 5 or higher. The score is determined by asking the person with colitis questions regarding:
• Bowel frequency at day/night Urgency of defecation Blood in stool General health Extracolonic manifestations

You may not qualify if:

• Those with concomitant systemic inflammation as Rheumatoid arthritis(RA) and Bronchial asthma (BA), those with a history of malignancy, Also, patients who were discovered to have autoimmune disease or microscopic colitis and Crohn's disease, ulcerative colitis patients who are on treatment.

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

Manal M kamel, Assistant lecture

CONTACT

01110071828; mkamal21967823@gmail.com

Khairy H Morsy, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: May 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 15, 2028
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR