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Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Sponsor: Ain Shams University
Summary
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
Key Details
Gender
All
Age Range
1 Month - 16 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-01-15
Completion Date
2026-12-13
Last Updated
2024-12-19
Healthy Volunteers
No
Conditions
Interventions
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.