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Oncostatin M in Ulcerative Colitis Patients

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oncostatin M
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ulcerative colitis Patients

    Control

    Arm Description

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

    45 apparently healthy subjects as controls who were not UC

    Outcomes

    Primary Outcome Measures

    Identify if oncostatin M is a good marker
    Diagnosis of Ulcerative colitis and follow up

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05974332
    Brief Title
    Oncostatin M in Ulcerative Colitis Patients
    Official Title
    Serum Oncostatin M in Ulcerative Colitis Patients and Its Relation to Severity and Acute Exacerbation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    99 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ulcerative colitis Patients
    Arm Type
    Active Comparator
    Arm Description
    45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    45 apparently healthy subjects as controls who were not UC
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Oncostatin M
    Intervention Description
    Test to diagnosis of Ulcerative colitis
    Primary Outcome Measure Information:
    Title
    Identify if oncostatin M is a good marker
    Description
    Diagnosis of Ulcerative colitis and follow up
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Oncostatin M in Ulcerative Colitis Patients

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