Evaluating post-operative outcomes in children with Crohn's Disease
Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study
This study is testing whether two different types of medicine can help prevent Crohn's Disease from coming back in children aged 6 to 17 after they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Schneider Children's Medical Center, Israel Academic / other |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 1 site (Petah Tikva, Israel) |
| Trial ID | NCT03681652 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of prophylactic therapy on clinical and endoscopic disease recurrence in children diagnosed with Crohn's Disease after undergoing ileo-cecal resection. It will compare the outcomes of patients receiving anti-TNF therapy versus those treated with thiopurines, with evaluations occurring at multiple time points over two years. The study will enroll patients aged 6 to 17 who have recently undergone surgery and will follow standard care protocols for post-operative assessments.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 years who have undergone ileo-cecal resection for Crohn's Disease within the last three months.
Not a fit: Patients with active perianal disease, renal failure, or other significant post-operative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing disease recurrence in pediatric Crohn's Disease patients post-surgery.
How similar studies have performed: Previous studies in adults have shown promising results with similar prophylactic approaches, indicating potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Petah Tikva, Israel
- Schneider Children's Hospital — Petah Tikva, Israel, Israel (Recruiting)
Study contacts
- Principal investigator: Amit Assa, MD — Schneider Children's Medical Center, Israel
- Study coordinator: Amit Assa, MD
- Email: dr.amit.assa@gmail.com
- Phone: +972543522211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.