Post-Operative Crohn's Disease Outcome in Children
Observational · No treatment assigned · 1 site · Schneider Children's Medical Center, Israel
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- Crohn's disease
- Age: 6 - 17 years (inclusive)
- L1 or L3 phenotypes
Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2019-02-11.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Israel.
Main thing being measured
- Endoscopic recurrence (Rutgeerts score ≥ i2b) (12 months following resection)
In the researchers’ words
Objectives: To examine the effect of prophylaxis therapy on clinical and endoscopic disease recurrence in children with Crohn's Disease (CD) following ileo-cecal resection. Hypothesis: Post-operative pediatric patients treated with anti-Tumor necrosis factor (TNF) prophylaxis will demonstrate lower endoscopic recurrence rates at 1 year and lower clinical recurrence rates at 2 years compared with thiopurines treated…
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Schneider Children's Medical Center, Israel |
| Enrollment | 100 (estimated) |
| Start date | 2019-02-11 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2018-09-24 |
| Last updated | 2025-05-15 |
| Official title | Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study |
| ClinicalTrials.gov ID | NCT03681652 |
Interventions
- Azathioprine (Drug)
Children with Crohn's disease who are treated with azathioprine for post-operative prophylaxis following ileo-cecal resection - Anti-TNF Drug (Drug)
Children with Crohn's disease who are treated with anti-TNF monotherapy for post-operative prophylaxis following ileo-cecal resection
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Crohn's disease 2. Age: 6 - 17 years (inclusive) 3. L1 or L3 phenotypes 4. Ileocecal resection in the previous 3 months 5. No active perianal disease (including draining fistula or a peri-anal abscess) 6. Prophylactic therapy with either thiopurines or anti-TNF has been initiated Exclusion Criteria: 1. Pregnancy 2. Renal Failure 3. Current abscess or perforation of the bowel 4. Post-operative intra-abdominal complication (fistula or abscess) 5. Complicated or heavily draining perianal fistula (indolent non-draining or minimally draining fistula are not an exclusion criteria). 6. Previous malignancy 7. Sepsis or active bacterial infection 8. IBD unclassified
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Schneider Children's Hospital | Petah Tikva, Israel | Israel | Recruiting |
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.