Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

Early Phase 1

Not yet recruiting

• Conditions: Effect of Drug
• Interventions: Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

• Registration Number: NCT06742606
• Lead Sponsor: Ain Shams University

Brief Summary

Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.

Detailed Description

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)

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-15
• Primary Completion: 2026-04-13
• Study Completion: 2026-12-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.

Ethical

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients diagnosed as IBD aged from 1 month to 16 years	Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab	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

Primary Outcome Measures

Name	Time	Method
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system	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