Not yet recruiting NCT06742606

Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

Early Phase I Interventional Effect of Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab.
Who it may be relevant to: Registry conditions: Effect of Drug. Basic parameters: 1 months — 16 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

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 b

Primary outcome measures

Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system [Time frame: 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06742606 · biological therapy and IBD

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗