Current Clinical Studies
Members of the Division of Gastroenterology, Hepatology and Nutrition at Cincinnati Children's Hospital Medical Center have a large number of active clinical studies which are listed on this page. For more information, please contact the division at 513-636-4415 or email us at gastro@cchmc.org. Normal office hours are Monday through Friday, 8:30 am to 4:30 pm.
Inflammatory Profile of Mononuclear Cells in Children with Jaundice
CCHMC IRB# 2008-0656
Type: Blood
Enrollment: Infants with newly diagnosed biliary atresia; patients followed to 18 mo or transplant. Also enrolling controls (normal infants and infants with other forms of neonatal cholestasis) for a single blood test
A Randomized, Double-Blind, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants with Biliary Atresia
CCHMC IRB #2008-0343
Type: Drug trial
Enrollment: Open to patients who are enrolled into the study "A Prospective Database of Infants with Cholestasis" (J. Bucuvalas, MD, principal investigator; see below) and undergo a portoenterostomy for the treatment of biliary atresia at Cincinnati Children's
A Prospective Database of Infants with Cholestasis
CCHMC IRB# 2008-0345
Type: Observational database
Enrollment: All infants <180 days of age who present with cholestasis (conjugated bilirubin > 2 mg/dL) for diagnostic work-up
Studies in Pediatric Liver Transplant (SPLIT)
CCHMC IRB# 2008-0174
Type: Observational national registry
Enrollment: Any patient <18 years old who has been listed for liver transplantation
Functional Outcomes of Pediatric Liver Transplantation: Health Related Quality of Life
CCHMC IRB# 2008-0482
Type: Parent and child questionnaire
Enrollment: Any liver transplant recipient <18 years of age who is 2 years post-transplant
Functional Outcomes of Pediatric Liver Transplantation: Cognitive Development and School Performance
CCHMC IRB #: 2008-0232
Type: Developmental testing
Enrollment: Liver transplant recipients between ages 5-7 and at least 2 years post-transplant
Pediatric Acute Liver Failure Study
CCHMC IRB# 2008-0494
Type: Observational database, blood, tissue, and urine repository.
Enrollment: All patients with acute liver failure. Study ends at discharge or transplant
Health Literacy and Health Outcomes in Pediatric Liver Transplantation
CCHMC IRB #: 2008-1417
Type: Questionnaire/Assessment
Enrollment: Open to all families of liver post-transplant patients ages 1-17 who are at least 1 year post-transplant
Mechanisms of Growth Hormone Resistance and Intestinal Inflammation in Colitis
CCHMC IRB# 2008-0625
Type: Tissue, blood
Enrollment: All patients (ages 5-18) undergoing diagnostic colonoscopy to rule out colitis
Risk Stratification & Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s disease
CCHMC IRB#2008-0764
Type: National registry, blood
Enrollment: Recently diagnosed Crohn’s disease, less than age 16
Biomarkers for Inflammatory Bowel Disease Behavior and Treatment Responses
CCHMC IRB# 2008-1622
Type: blood
Enrollment: Genetic study for family members of children with inflammatory bowel disease
Analysis of Susceptibility Genes in Inflammatory Bowel Disease
CCHMC#2008-0547
Type: blood
Enrollment: Patients diagnosed with Inflammatory Bowel Disease before age 21
Pediatric Inflammatory Bowel Disease Registry
CCHMC IRB#:2008-0389
Type: National Registry, data collection.
Enrollment: Recently diagnosed inflammatory bowel disease
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis
CCHMC IRB #: 2008-0428
Type: Observational database and blood and tissue repository.
Enrollment: Open to patients up to age 23 who have been diagnosed with one of the following liver diseases: alagille syndrome, alpha-1 antitrypsin deficiency, bile acid synthesis defect or progressive familial intrahepatic cholestasis
Intralumenal Effects on Cholesterol Absorption/Synthesis
CCHMC IRB# 05-04-10
Type: Dietary study
Enrollment: Healthy adults, age 19-40, with no chronic diseases or food allergy and on no medications including birth control pills
Inborn Errors of Bile Acid Metabolism (with Kenneth Setchell, PhD)
CCHMC IRB# 91-10-10
Enrollment: Infants and children with cholestasis who are suspected clinically of having an inborn error of bile acid metabolism
A Multi-Center-Study of the Safety and Efficacy of N-Acetylcysteine in the Treatment of Acute Liver Failure Not Caused by Acetaminophen in Pediatric Patients
CCHMC IRB #: 2008-0162
Type: Drug Trial
Enrollment: Open to children admitted with acute liver failure not caused by acetaminophen and who are enrolled in the Pediatric Acute Liver Failure Study
Alexander Miethke, MD
Biliary Atresia Study in Older Infants, Children, and Adults
CCHMC IRB #: 2008-0363
Type: Observational database and blood repository
Enrollment: Observational database of children with biliary atresia > 1 year of age.
Longitudinal Study of Mitochondrial Hepatopathies
CCHMC IRB #: 2008-1300
Type: Observational database and blood and tissue repository
Enrollment: Children and young adults up to age 18 with suspected or documented primary mitochondrial hepatopathies of either respiratory chain defects (RC) or fatty oxidation defects (FAO)
Charles Samson, MD
Inflammatory Bowel Disease (IBD) Registry
CCHMC IRB# 2008-0369
Type: National database
Enrollment: Patients up to age 16 who have newly diagnosed inflammatory bowel disease. Study involves documenting the clinical course and response to therapies prescribed by the treating physician over a 2-5 year period
Quality of Life Questionnaire for Children After Liver Transplantation (Validity)
CCHMC IRB# 2008-0046
Type: Patient questionnaire
Enrollment: Liver transplant recipients
Pediatric Nonalcoholic Fatty Liver Disease Registry
CCHMC IRB # 2008-0258
Type: Data collection
Enrollment: Children and adolescents diagnosed with NASH/NAFLD
