Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system
研究概览
简要总结
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
详细描述
IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica & Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer & Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ).
In2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor & Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.
- •Patients initially severely diseased or in relapse and planned to start or change biological therapy.
排除标准
- •Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.
研究组 & 干预措施
patients diagnosed as IBD aged from 1 month to 16 years
study will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group
1 of patients will receive Adalimumab while Group 1 will receive ustekinumab
干预措施: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab (Biological)
结局指标
主要结局
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system
时间窗: 48 weeks
response to treatment Frequency of relapses, Control of symptoms and Following up growth pattern. histopathological scoring assessment will be by using Inflammatory Bowel Disease-Distribution, Chronicity, Activity \[IBD-DCA\] Score
次要结局
未报告次要终点
