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Oncostatin M in Ulcerative Colitis Patients

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ClinicalTrials.gov Identifier: NCT05974332
Recruitment Status : Not yet recruiting
First Posted : August 3, 2023
Last Update Posted : August 3, 2023
Sponsor:
Information provided by (Responsible Party):
mohamed gamal mohamed abdel aleem, Beni-Suef University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Identify if oncostatin M is a good marker [ Time Frame: 6 months ]
    Diagnosis of Ulcerative colitis and follow up


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: mohamed gamal mohamed abdel aleem, Doctor, Beni-Suef University
ClinicalTrials.gov Identifier: NCT05974332    
Other Study ID Numbers: Beni-Suefu
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Oncostatin M
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs