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Gastroenterology Research

Connecticut Children’s is among the most active in the country for basic, clinical and translational research. Our nationally-recognized gastroenterologists lead and collaborate on 32 IRB-approved studies, including NIH- and privately-funded digestive diseases research projects.

Studies Open for Enrollment

A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients with Moderately to Severely Active Ulcerative Colitis (SHINE-1)
Sponsor: Eli Lilly
Summary: This study is designed to evaluate the pharmacokinetics, safety, and disease response of mirikizumab in pediatric participants with Ulcerative Colitis (UC).
Site Principal Investigator: Jeffrey Hyams, MD
Key eligibility: Ages 2-17 with moderately to severely active UC, failed previous treatments

Open-label induction and maintenance study of oral cp-690,550 (tofacitinib) in children with moderately to severely active ulcerative colitis (OVATION)
Sponsor: Pfizer
Summary: This study is to evaluate the efficacy, safety and pharmacokinetics of tofacitinib in pediatric participants with moderately to severely active UC.
Site Principal Investigator: Jeffrey Hyams, MD
Key eligibility: Ages 2-17 with moderately to severely active UC, failed anti-TNF treatment

Dosing and Pilot Efficacy of 2′-Fucosyllactose in Inflammatory Bowel Disease
Sponsor: NIH/NICHD through Cincinnati Children’s Hospital Medical Center
Site Principal Investigator: Jeffrey Hyams, MD
Summary: This study will assess the safety, tolerability, and efficacy of a prebiotic in promoting the growth of beneficial intestinal bacteria in children and young adults with inflammatory bowel disease (IBD) in stable remission on anti-TNF therapy.
Key eligibility: Phase I will enroll participants aged 18-25 with IBD in remission on a stable dose of anti-TNF

Pathogenic Heterogeneity in Mucosal Stem Cells in Pediatric Crohn’s Disease
Sponsor: NIH, through the University of Houston
Site Principal Investigator: Jeffrey Hyams, MD
Summary: The focus of this study is to assess the adult stem cell profile of biopsies taken from patients with active Crohn’s disease (CD) and corresponding biopsies after they achieve clinical remission.
Key eligibility: Patients aged 7-17 with active CD scheduled for a clinically indicated colonoscopy

Development and evaluation of the TUMMY CD-index: A Patient Reported Signs and Symptom Index for Pediatric Crohn’s Disease
Sponsor: IWK Health Centre
Site Principal Investigator: Jeffrey Hyams, MD
Summary: This study aims to develop a pediatric patient reported outcome tool that is valid and reliable to assess symptoms and disease activity for pediatric CD.
Key eligibility: Patients aged 4-17 with CD and their caregivers

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis (NASH)
Sponsor: Target PharmaSolutions
Site Principal Investigator: Karan Emerick, MD
Summary: This is a 5-year, international, longitudinal, observational study of patients with nonalcoholic fatty liver disease designed to specifically address important clinical questions that remain incompletely answered from registration trials.
Key eligibility: Patients aged 2 or older being managed or treated for nonalcoholic fatty liver disease

Selected Studies in Follow-up (Not Enrolling):

Precision Crohn’s Disease Management Utilizing Predictive Protein Panels (ENvISION)
Sponsor: Helmsley Charitable Trust, through Cincinnati Children’s Hospital Medical Center
Site Principal Investigator: Jeffrey Hyams, MD
Summary: The goal of this study is to develop a blood test that accurately predicts the probability of deep remission with anti-TNF treatment, and a protein biomarker panel that distinguishes endoscopic mucosal healing from active intestinal inflammation in patients with CD.

Predicting response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (VEDOKIDS)
Sponsor: Shaare Zedek Medical Center
Site Principal Investigator: Jeffrey Hyams, MD
Summary: This study aims to prospectively explore the short term and long term outcomes of treatment with vedolizumab in a pediatric population, and to develop a prediction model for treatment success.

Monitoring Serologic Response to SARS-CoV-2 in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)
Site Principal Investigator: Jeffrey Hyams, MD
Summary: This study will characterize critical pathways in the immune response to SARS-CoV-2 (COVID-19) and the COVID-19 vaccine in young individuals with IBD or juvenile idiopathic arthritis receiving maintenance immunosuppressive therapy.

Pharmacodynamic Targets to Enrich Personalized Anti-TNF Dosing (RADAR)
Sponsor: Crohn’s & Colitis Foundation, through Cincinnati Children’s Hospital Medical Center
Site Principal Investigator: Jeffrey Hyams, MD
Summary: The global aim of this study is to identify biochemical and drug concentration targets for pediatric onset CD in order to personalize anti-TNF dosing regimens and improve long-term outcomes.

DEVELOP Registry: A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease
Sponsor: Janssen
Site Principal Investigator: Jeffrey Hyams, MD
Summary: The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with IBD, particularly in association with infliximab and other prescribed IBD therapies.

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn’s Disease (CD) – CAPE
Sponsor: Abbvie
Site Principal Investigator: Jeffrey Hyams, MD
Summary: This is a global, multicenter, non-interventional registry of pediatric patients with moderately to severely active CD treated in a routine clinical setting with Humira or other immunosuppressant therapy.

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1 – 6 Chronic Hepatitis C Virus (HCV) Infection (DORA)
Sponsor: Abbvie
Site Principal Investigator: Karan Emerick, MD
Summary: This is study to evaluate the pharmacokinetics, efficacy, and safety of glecaprevir/pibrentasvir in pediatric participants with Hepatitis C virus genotype 1-6 (GT1 – GT6).

For more information or questions, please e-mail GIResearch@connecticutchildrens.org

 

 

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