Oncostatin M in Ulcerative Colitis Patients

Sponsor

Beni-Suef University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05974332

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea, bloody stools, and abdominal pain with repeated relapses and remissions.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Diagnostic Test: Oncostatin M	N/A

Detailed Description

Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation can facilitate subsequent prognostication. On the basis of these considerations, achievement of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD using endoscopy is extremely important. However, endoscopic examinations are associated with problems such as physical burden to the patient, cost, and risk of complications.

Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal immunochemical occult blood test (FIT) are being widely used in clinical practice.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Serum Oncostatin M in Ulcerative Colitis Patients and Its Relation to Severity and Acute Exacerbation

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ulcerative colitis Patients 45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding	Diagnostic Test: Oncostatin M Test to diagnosis of Ulcerative colitis
Active Comparator: Control 45 apparently healthy subjects as controls who were not UC	Diagnostic Test: Oncostatin M Test to diagnosis of Ulcerative colitis

Arm

Intervention/Treatment

Active Comparator: Ulcerative colitis Patients

45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding

Diagnostic Test: Oncostatin M

Test to diagnosis of Ulcerative colitis

Active Comparator: Control

45 apparently healthy subjects as controls who were not UC

Diagnostic Test: Oncostatin M

Test to diagnosis of Ulcerative colitis

Outcome Measures

Primary Outcome Measures

Identify if oncostatin M is a good marker [6 months]
Diagnosis of Ulcerative colitis and follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All patients aged >18 years and <80 years, of both gender who diagnosed to have UC and given the consent for participation in the study

Exclusion Criteria:

1- Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus erythematous

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohamed gamal mohamed abdel aleem, Doctor, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT05974332

Other Study ID Numbers:

Beni-Suefu

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023