Pediatric Crohn’s Disease: Endoscopic and Imaging Healing with Anti-TNF Therapy
Official title: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn's Disease
Funded at Connecticut Children's Medical Center · NIH-11364977 · Data updated 2026-11-12
A large pediatric study will look at how endoscopic healing and imaging healing relate to pre-treatment factors in kids newly diagnosed with Crohn’s disease who start anti-TNF therapy.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Connecticut Children's Medical Center NIH-funded |
| Lab location | 1 site (Hartford, United States) |
| Project start | April 1, 2023 |
| Project end | March 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $2,800,000 |
| NIH project number | 5U01DK134356-04 |
| Project ID | NIH-11364977 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children newly diagnosed with Crohn’s disease who are started on anti-TNF therapy within six months of diagnosis.
✕Less likely to help
Children not treated with anti-TNF or not undergoing regular endoscopic/imaging assessment may not benefit from these findings.
What this research studies
This project follows 550 children with newly diagnosed Crohn’s disease who begin anti-TNF treatment within six months of diagnosis. Researchers will collect clinical data, radiology images, and biological samples before starting therapy and track endoscopic healing and imaging healing 52 weeks later. They’ll analyze how pre-treatment nutritional status, microbial factors, and other baseline measurements predict healing outcomes, using careful statistical methods. The study aims to connect baseline patient characteristics with the likelihood of complete healing, which combines endoscopic and imaging improvements, and with major secondary healing endpoints.
Why it matters
Potential benefit: If successful, the findings could help doctors tailor anti-TNF treatment to kids most likely to achieve complete healing, potentially reducing hospitalizations and surgeries.
How similar studies have gone: Previous pediatric studies suggest baseline factors can influence healing, but this project tests a comprehensive set of predictors in a large, prospective cohort.
Where this research is happening
-
Connecticut Children's Medical Center
Hartford, United States Active
Researchers
- Principal investigator: Hyams, Jeffrey Samuel — Connecticut Children's Medical Center
- Study coordinator: Hyams, Jeffrey Samuel
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.