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临床试验/NCT06959654
NCT06959654尚未招募不适用

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

Sohag University0 个研究点目标入组 90 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Assessment of Serum value of oncosatin M and galactin 3 patients with ulcerative colitis

研究概览

简要总结

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).

详细描述

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).

With 505 new cases per 100,000 people, Europe now has the highest prevalence of UC, followed by North America with 249 new cases per 100,000 people (Al-Fawzan et al., 2023), With an annual percentage rise of 4.3% (Kucharzik et al., 2020), it is becoming increasingly commonplace worldwide as more nations adopt Westernized lifestyles, leading to fast increases in incidence rates.

The aetiology involves interactions between the environment, immune system, gut microbiome and a genetic predisposition to disease (Kobayashi et al., 2020).

Ulcerative colitis presents with bloody diarrhea, frequency, abdominal pain, fatigue and faecal incontinence.

The pathogenesis of UC has not been elucidated yet, but it is supposed to be a consequence of unbalanced expression of molecules that have both anti- and pro-inflammatory properties (Ogino et al., 2021).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Group 1 :-normal healthy patients

Active Comparator

The study group will include 40 normal healthy subject.

干预措施: ELISA test (Diagnostic 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.

干预措施: ELISA test (Diagnostic Test)

结局指标

主要结局

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

时间窗: 1year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

manal mostafa kamel

Assistant lecture

Sohag University

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