Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

April 13, 2026

Study Completion Date

December 13, 2026

Conditions
Effect of Drug
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 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."

All Listed Sponsors
lead

Ain Shams University

OTHER