Health TrialsbyHealthPanel

Conventional vs Biologic Therapy in Pediatric IBD

ConditionsInflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- Incomplete medical records precluding assessment of primary endpoints

Age more than 18 years

Discontinuation of follow-up before a minimum evaluable treatment period

Trial population

Children and adolescents up to 18 years of age with confirmed inflammatory bowel disease receiving conventional and/or biologic therapy at Assiut University Children Hospital and the Health Insurance IBD Committee, Assiut Branch.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Conventional Therapy
Group B: Biologic Therapy

Trial outcomes

Primary outcomes

1

Clinical remission rate

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.

Time frame
At week 8-12, 6 months, and 12 months

Secondary outcomes

1

Clinical response rate

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).

Time frame
At week 8-12, 6 months, and 12 months
2

Steroid-free remission rate

Proportion of patients in clinical remission without systemic corticosteroid use.

Time frame
At 12 months
3

Incidence of adverse events

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

Time frame
Through 12 months
4

Change in growth parameters

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

Time frame
From baseline to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: