Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

ConditionEffect of Drug

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age1-16

SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab
Biological/Vaccine
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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: patients diagnosed as IBD aged from 1 month to 16 yearsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system

response to treatment Frequency of relapses, Control of symptoms and Following up growth pattern. histopathological scoring assessment will be by using Inflammatory Bowel Disease-Distribution, Chronicity, Activity \[IBD-DCA\] Score

Time frame

48 weeks

Locations

This trial has no locations.

Sponsors and contacts

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

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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