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NCT Number: NCT06742606

Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

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

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Key information

Conditions

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

Biological

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.

Primary outcomes

  1. Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed nageh abdelhamed, master degree in pediatrics

CONTACT

[email protected] ext. 2001150181507

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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