Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

Sponsor
Ain Shams University
Study ID
NCT06742606
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Effect of Drug

Eligibility Criteria

Sex
ALL
Age
1 Month - 16 Years
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2024
Primary completion
Apr 13, 2026
Completion
Dec 13, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: patients diagnosed as IBD aged from 1 month to 16 years
    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

Primary Outcome Measure

Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system [ Time Frame: 48 weeks ]

Central Contacts

Related Studies