Conventional vs Biologic Therapy in Pediatric IBD

Effectiveness, Safety, and Adverse Events of Conventional and Biologic Therapy in Pediatric Inflammatory Bowel Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07818473

Enrollment

100

Registered

2026-09-14

Start date

2026-09-10

Completion date

2028-01-10

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis

Keywords

Pediatric IBD, Biologic therapy, Conventional therapy, Infliximab, Adalimumab, PCDAI, PUCAI, Assiut

Brief summary

This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.

Detailed description

Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission. This observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* \- Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria * Age at diagnosis less than 18 years * Receipt of conventional therapy and/or biologic therapy for a minimum evaluable treatment duration * Availability of adequate medical records * Written informed consent (for prospective component)

Exclusion criteria

* \- Incomplete medical records precluding assessment of primary endpoints * Age more than 18 years * Discontinuation of follow-up before a minimum evaluable treatment period

Design outcomes

Primary

Measure	Time frame	Description
Clinical remission rate	At week 8-12, 6 months, and 12 months	Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI \< 10 for ulcerative colitis.

Secondary

Measure	Time frame	Description
Clinical response rate	At week 8-12, 6 months, and 12 months	Proportion of patients achieving clinical response, defined as a decrease from baseline of ≥12.5 points in PCDAI (Crohn's disease) or ≥20 points in PUCAI (ulcerative colitis).
Steroid-free remission rate	At 12 months	Proportion of patients in clinical remission without systemic corticosteroid use.
Incidence of adverse events	Through 12 months	Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria
Change in growth parameters	From baseline to 12 months	Change in height z-score, weight z-score, and BMI z-score from baseline.
Treatment escalation or switch rate	Through 12 months	Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.

Contacts

CONTACTElizabeth M lshak, Resident

elithabeth.17289856@med.aun.edu.eg01221541345

STUDY_CHAIRNafisa H Abdel-Aziz, prof

Pediatrics Department, Assiut University Hospitals

Outcome results