Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Early Phase 1 · Testing Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab · Sites not listed yet · Ain Shams University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab (a biologic) as a possible treatment. Condition(s) listed: Effect of Drug.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 1 Month to 16
- Any sex
Some of the main requirements, copied from the record:
- Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.
- Patients initially severely diseased or in relapse and planned to start or change biological therapy.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-01-15 (planned).
- Main results expected around 2026-04-13 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system (48 weeks)
In the researchers’ words
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Effect of Drug |
| Lead sponsor | Ain Shams University |
| Enrollment | 40 (estimated) |
| Start date | 2025-01-15 |
| Primary completion (est.) | 2026-04-13 |
| First posted | 2024-12-19 |
| Last updated | 2024-12-19 |
| Official title | Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06742606 |
Interventions
- Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab (Biological)
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 Inde…
Full eligibility criteria (from the record)
Inclusion Criteria: Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings. Patients initially severely diseased or in relapse and planned to start or change biological therapy. Exclusion Criteria: Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency. Ethical
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.