Clinical trial NCT06742606: Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Official title: Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Effect of Drug
Keywords: biological therapy , IBD
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients diagnosed as IBD

Inclusion Criteria:

1. Age: patients diagnosed as IBD aged from 1 month to 16 years
2. Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings (Levine et al, 2014).
3. Patients initially severely diseased or in relapse and planned to start or change biological therapy.

Exclusion Criteria:

1. Patients already on biological therapy and controlled.
2. Patients with known humeral or cell mediated immunodeficiency.
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: