Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

NCT06742606 | Not Yet Recruiting Early Phase 1

• 1 other identifier: biological therapy and IBD
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Effect of Drug

Keywords

biological therapy , IBD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients diagnosed as IBD aged from 1 month to 16 years

EXPERIMENTAL

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

Interventions

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.

patients diagnosed as IBD aged from 1 month to 16 years

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Mohamed nageh abdelhamed, master degree in pediatrics

CONTACT

hossam26620@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 19, 2024
• Study Start: January 15, 2025
• Primary Completion: April 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-11