Children's Inflammatory Bowel Disease (IBD) Research and Clinical Studies

UPMC Children's Hospital of Pittsburgh is a top U.S. gastroenterology research center. This allows our children's GI, hepatology, and nutrition experts to take part in the latest IBD clinical studies.

Studies help us further learn about GI health issues and digestive disorders in kids.

UPMC Children's Hospital is a leader in studies that occur at more than one center. This means experts from around the world work together and share what they learn.

IBD is a main focus of our research.

Children with IBD in these studies take part in local and national registries to:

Gather data about treatments and outcomes.
Measure the success and safety of medicines.

Our current studies related to IBD include:

Skyrizi (MIGHTY)

Ulcerative Colitis: PK, Efficacy, and Safety of Risankizumab in Pediatric UC
PI: Whitney Sunseri, MD
Design: Phase 3, multicenter
Objective: Demonstrate superior efficacy vs external placebo for clinical remission
Details:

Ages 2–17, moderate–severe UC.
12-week single-arm open-label induction.
Randomized double-blind maintenance.
SOC endoscopies: baseline & 6–9 months (recorded).
Biopsy samples collected.
Clinical remission assessed at week 64.

CAMEO

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn’s Disease
PI: Whitney Sunseri, MD
Design: Prospective, multicenter, open-label, single-arm trial
Objective: Identify clinical, radiologic, genomic, immune, and microbial factors linked to complete intestinal healing with optimized anti-TNF therapy in newly diagnosed pediatric CD.
Phases:

Phase 1:
- Ages 6–17, suspected CD.
- Recruitment: inpatient, prior to scope.
- Diagnostic ileocolonoscopy (recorded).
- Blood & biopsy specimens collected.
- Baseline MRE.
Phase 2:
- Confirmed CD from Phase 1.
- Start anti-TNF therapy using RoadMab guidance.
- Repeat scope & MRE at ~52 weeks.

COMBINE

Implementing COMBINE Trial Results in ICN Learning Health Network
PI: Whitney Sunseri, MD
Design: Pilot implementation in 8 ICN centers
Objective: Disseminate COMBINE trial results & support adoption
Key Findings:

Adalimumab + low-dose methotrexate beneficial.
Infliximab + methotrexate not beneficial.

Details:

Patients ≥13 & caregivers.
Recent visit discussing TNF initiation.
Shared decision-making tools & care algorithms.
Develop/test implementation strategies.

COMPARE

Clinical Outcomes of Medications Post Anti-TNF in Pediatric IBD
PI: Whitney Sunseri, MD
Design: Multicohort observational study
Objective: Compare effectiveness & safety of newer IBD meds in TNF-refractory pediatric patients
Cohorts:

CD.
UC & IBD-U.

Details:

Ages <18, diagnosed CD or UC.
Patient-reported outcomes.
12-month follow-up.

Nicotinamide Riboside in Ulcerative Colitis

A Pilot Study of Nicotinamide Riboside in Pediatric UC
PI: Kevin Mollen, MD | GI PI: Whitney Sunseri, MD
Design: Pilot clinical trial
Objective: Assess if NR improves mitochondrial function in small intestine
Details:

Ages 6–18, mild–moderate UC.
Randomized: NR vs placebo (with SOC).
NR capsule: swallow whole or sprinkle in food.
Colonoscopy at enrollment & 6–12 months.
Tissue & stool samples collected.

REMODEL-CD

Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric CD
PI: Whitney Sunseri, MD
Design: Open-label, cluster-randomized trial
Objective: Test if precision infliximab dosing with targeted concentration is superior to conventional dosing
Details:

Ages 6–22, new CD diagnosis (<90 days).
Anti-TNF naïve, starting infliximab.
Drug provided at no cost.
UPMC = conventional site.

If you have questions regarding research studies, please contact giresearchgroup@upmc.edu.

Contact the IBD Center at UPMC Children's Hospital of Pittsburgh

We welcome referrals and second opinions. You can also schedule your child's visit on your own. To learn more or make an appointment with an IBD expert at UPMC Children's, fill out our contact form, or call 412-692-5180.