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
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis | Diagnostic Test: Oncostatin M | Not Applicable |
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 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 |
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
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Diagnostic Test: Oncostatin M
Test to diagnosis of Ulcerative colitis |
Active Comparator: Control
45 apparently healthy subjects as controls who were not UC
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Diagnostic Test: Oncostatin M
Test to diagnosis of Ulcerative colitis |
- Identify if oncostatin M is a good marker [ Time Frame: 6 months ]Diagnosis of Ulcerative colitis and follow up
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Ages Eligible for Study: | Child, Adult, Older Adult |
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
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |