Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Effect of Drug
• Intervention / Treatment: Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed nageh abdelhamed, master degree in pediatrics; Phone Number: 2001150181507 hossam26620@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab; All the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment • response to treatment Frequency of relapses, Regular assessment will be: Clinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems: pediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index Laboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by: Disease activity: Laboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system	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	48 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): April 13, 2026
• Study Completion (Estimated): December 13, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: biological therapy , IBD
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adalimumab; Ustekinumab
• Other Study ID Numbers: biological therapy and IBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No