The Association of Pediatric Gastroenterology and Nutrition Nurses
Help & Hope for Children with Digestive Disorders GIKids
Journal of Pediatric Gastroenterology and Nutrition Journal of Pediatric Gastroenterology and Nutrition

Research Opportunities

Hepatitis B in children can lead to social stigmatism, cirrhosis, cancer and endstage liver disease, yet our knowledge of the problem of pediatric HBV in North America is insufficient. To meet this gap, the NIDDK-funded Hepatitis B Research Network is launching both a pediatric cohort study to describe the natural history of this disease in children and a clinical trial for immunotolerant children. There are 7 pediatric sites: Johns Hopkins University School of Medicine (Kathy Schwarz, M.D., PI); St. Louis University (Jeff Teckman, M.D.); UCSF (Phil Rosenthal, M.D.); University of Minnesota (Sarah Jane Schwarzenberg, M.D.); University of Texas Southwest (Norberto Rodriguez-Baez, M.D.), University of Toronto (Simon Ling, M.D.); and the University of Washington (Karen Murray MD). We hope to enroll 500 children in the cohort study and 250 children in the immunotolerant trial.
Details
Descriptionhttp://www.clinicaltrials.gov/ Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection.

Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21)
This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute, and the Office of Dietary Supplements (ODS) of the National Institutes of Health encourages pilot and feasibility clinical and epidemiological research studies of new therapies or means of health promotion and prevention of digestive and liver diseases and nutritional disorders associated with digestive and liver diseases.
“Additional areas of special focus of this funding opportunity are hepatitis B and C. These two diseases are major causes of morbidity and mortality from liver disease in the United States. Current estimates suggest that chronic hepatitis B affects 1 million and hepatitis C approximately 3 million Americans.

Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21)
Specific examples of research areas of interest include but are not limited to:
Disorders of GI function, including irritable bowel syndrome, gastroparesis, non-ulcer dyspepsia, colonic inertia, pseudo-obstruction, ileus, and cyclic vomiting syndrome.

NAFLD Pediatric Database 2
http://www.clinicaltrials.gov/ct2/show/NCT01061684

Pediatric Liver Database
http://www.clinicaltrials.gov/ct2/show/NCT00677625

A Pilot Study of Acarbose as Treatment for Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)
http://www.clinicaltrials.gov/ct2/show/NCT00677521

Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
http://www.clinicaltrials.gov/ct2/show/NCT01088607

Evaluating the Genetic Causes and Progression of Cholestatic Liver Diseases
http://www.clinicaltrials.gov/ct2/show/NCT00571272

Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury
http://www.clinicaltrials.gov/ct2/show/NCT01089426

Efficacy Study of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
http://www.clinicaltrials.gov/ct2/show/NCT01115582

A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic HBV-Infection
http://www.clinicaltrials.gov/ct2/show/study/NCT01079806

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
http://www.clinicaltrials.gov/ct2/show/NCT00423891

Biliary Atresia Research Consortium (PROBE)
http://www.clinicaltrials.gov/ct2/show/NCT00061828

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
http://www.clinicaltrials.gov/ct2/show/NCT01062815

A Multi-Center Group to Study Acute Liver Failure in Children
http://www.clinicaltrials.gov/ct2/show/NCT00986648

Development of Biomarker for Development of Non-Alcoholic Steatohepatitis (NASH) in Children
http://www.clinicaltrials.gov/ct2/show/NCT00677183


Pediatric Resource Organization for Kids with Inflammatory Intestinal Diseases (PROKIIDS) and Pediatric IBD Research Network

The Pediatric IBD Research Network is now extending a request for participation to the NASPGHAN community through this communication. Our intent is to add an additional 7-10 centers to the current 13 (7 active, 6 in process of becoming active) over the next 4-6 months. The application form for centers that are interested in being considered for participation can be accessed here. Eligibility is based on qualifications as detailed on the application form and final decisions will be made by the selection committee composed of members of the Pediatric Network, the NASPGHAN IBD committee, and CCFA. Selection continues until all spots are filled and applications will be considered on a first come, first considered basis.

We appreciate your interest and look forward to your possible participation. Please contact any one of us listed here with questions.

Jeffrey Hyams, MD
Co-Chair, Selection Comm.
Robert Baldassano, MD
Co-Chair, Selection Comm.
Subra Kugathasan, MD
Principal Investigator


Small Grant Program for NIDDK K01/K08/K23 Recipients (R03)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Dietary Supplements (ODS) announce a program that provides NIDDK-supported K01, K08 and K23 recipients the opportunity to apply for Small Grant (R03) support to run concurrently with the latter years of their K award. Through the use of this mechanism, which allows up to $50,000 direct costs per year for two years in additional research development costs, the NIDDK is seeking to enhance the capability of its K01, K08 and K23 award recipients to conduct research as they complete their transition to fully independent investigator status. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support research projects that can be carried out in a short period of time with limited resources.
"Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases"
For information on NIH's Role in the American Recovery and Reinvestment Act, issued Feb. 25, 2009, refer to:
Grant Funding Opportunities web site
The Challenge Grant Funding Opportunity Announcement
The Challenge Grant Web site
RFA-RR-09-007 - Recovery Act Limited Competition: Core Facility Renovation, Repair, and Improvement (G20)
RFA-RR-09-008 - Recovery Act Limited Competition: Extramural Research Facilities Improvement Program (C06)
PAR-09-118 - Recovery Act Limited Competition: High-End Instrumentation Grant Program (S10)
NOT-RR-09-008 - Addition of Recovery Funds to the Shared Instrumentation Grant Program



The purpose of the T-R01 Program is to support exceptionally innovative, original or unconventional research that will allow investigators to seize unexpected opportunities and cultivate bold ideas regardless of the anticipated risk. T-R01 funding will support inventive and innovative studies intended to transform current paradigms in biomedical or behavioral sciences.
Additional information about the Transformative R01 Program is available at: http://www.nihroadmap.nih.gov/grants/index.asp