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Research & Scholarly Activity

Our current research initiatives include:

  • Liver Disease in Childhood
  • Liver Transplantation in Childhood
  • Gastrointestinal and nutritional conditions associated with chronic diseases of childhood
  • Total parenteral nutrition-induced cholestasis
  • Irritable bowel syndrome
  • Inflammatory bowel disease
  • Chronic abdominal pain of childhood
  • Malabsorption, celiac disease, and digestive enzyme deficiency conditions in infants and children
  • Capsule endoscopy in children

Clinical trials that test new therapies are being performed in many areas, especially in inflammatory bowel disease. The clinical research center is often used to provide easy access for patients and their families to participate in the studies.

Current Projects

Lawrence J. Saubermann, M.D., Chief

  • Safety and efficacy of vedolizumab in patients with ulcerative colitis and Crohn’s disease. This clinical trial continues from earlier randomized studies comparing vedolizumab vs. placebo to study long-term vedolizumab treatment in patients with ulcerative colitis or Crohn’s disease. Millennium Pharmaceuticals
  • Evaluating the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease. This clinical trial continues from the induction study comparing ustekinumab vs. placebo to study maintenance of the drug over 3 years. Janssen Research & Development
  • Evaluating efficacy and safety of SAR339658 in patients with active moderate to severe ulcerative colitis (UC). This randomized trial compares placebo to an intravenous treatment for ulcerative colitis. Sanofi US Services Inc.
  • Oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. This randomized trial compares placebo to an investigational oral medication for ulcerative colitis. Pfizer
  • CB-183,315 in patients with clostridium difficile associated diarrhea. This randomized trial compares vancomycin to an investigational antibiotic for C difficile. Cubist Pharmaceuticals, Inc.

Rebecca Abell, D.O.

  • Retrospective review of effect of positional modifications on gastric transit time after oral ingestion of WCE in pediatric patients. University of Rochester, Golisano Children's Hospital, August 2014 – present.
  • The human anti-TNF monoclonal antibody adalimumab in pediatric subjects with moderate to severe ulcerative colitis. ABBVIE study, April 2015 - present.

Marilyn R. Brown, M.D.

  • Parenteral nutrition and inflammatory bowel disease.

Megan Gabel, M.D.

  • Developing innovating gastroenterology specialty training (DIGEST) program, Cystic Fibrosis Foundation, May, 2016.

Nanda Kerkar, M.D.

  • The Global Alagille Alliance Study (GALA). Our participation in this registry is part of an international, retrospective, multicenter cohort study to determine the prevalence and natural history, socio-economic burden, and outcomes of individuals with Alagille syndrome (ALGS), with a focus on extrahepatic manifestations.
  • Long-term Outcome and Risk Stratification In Autoimmune Hepatitis (LORSIAH) – an International, Multicenter Retrospective Observational Study. Our participation in this registry is part of an international, retrospective, multicenter cohort study to ascertain the long-term outcomes and predictors of death and/or liver transplantation in patients with autoimmune hepatitis (AIH). The goal of this registry is to investigate surrogate end points of long-term outcomes to monitor disease progression and evaluate treatments. This collaborative effort will help improve treatment strategies and support clinical management and decision-making of treatment of AIH.
  • Pediatric Primary Sclerosing Cholangitis Outcomes Study. This is a multicenter collaborative effort to evaluate: long term outcomes of pediatric PSC, characteristics of pediatric patients who have poor outcomes, differences between small duct and large duct PSC subtypes, and the effects of ursodeoxycholic acid use in pediatric PSC. Primary sclerosing cholangitis is a chronic, immune-mediated, liver disease, which is rare in children, with few studies containing large numbers of children that describe outcomes and risk factors for progressive disease.
  • Studies of Pediatric Liver Transplantation (SPLIT). This study has the opportunity to be at the front of the wave to help the health care community understand the critical role of registries for disease specific populations. The objectives of this study are to improve outcomes in children receiving liver transplants by collecting data that will serve as a foundation for targeted clinical studies, whether quality improvement/comparative effectiveness studies or clinical trials. Analyses of the data set and assessing outcomes will form a foundation for patient-based research and will guide quality improvements in care. The aim is to:
    • Collect prospective data from pediatric liver transplant centers which permit opportunities to identify and improve early post-transplant outcomes. The focus will be on patient and graft survival, length of stay and readmission.
    • Prospectively collect data from pediatric liver transplant survivors more than one year after transplant to, identify emerging outcomes, clarify predictors for known outcomes and identify best practices. Analyses will also serve to help prevent and mitigate immune and non-immune complications.
  • A Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated with Cholbam®/Kolbam® (Cholic Acid)

    Purpose: The primary objective of this study is to describe the long-term safety of treatment with Cholbam, a medication that has been designed to replace a bile acid that is not being produced as a result of a genetic defect in bile acid synthesis.

Nishaben Patel, M.D.

  • Inflammatory bowel disease, diagnostic and therapeutic endoscopy as well as video capsule endoscopy.

Fellowship Research