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Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

NCT06742606 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-19

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-04-13
Completion
2026-12-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06742606 on ClinicalTrials.gov