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NCT Number: NCT07818473

Conventional vs Biologic Therapy in Pediatric IBD

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical remission rate

    Time frame: 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 outcomes

  1. Clinical response rate

    Time frame: 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).

  2. Steroid-free remission rate

    Time frame: At 12 months

    Proportion of patients in clinical remission without systemic corticosteroid use.

  3. Incidence of adverse events

    Time frame: Through 12 months

    Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria

  4. Change in growth parameters

    Time frame: From baseline to 12 months

    Change in height z-score, weight z-score, and BMI z-score from baseline.

  5. Treatment escalation or switch rate

    Time frame: Through 12 months

    Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth M lshak, Resident

CONTACT

[email protected]

01221541345

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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