Gastroenterology, Hepatology and Nutrition

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 and select option 2 or email us at gastro@cchmc.org. Normal office hours are Monday through Friday, 8:30 am to 4:30 pm.

William F. Balistreri, MD

Pegylated Interferon +/— Ribavirin for Children with HCV
CCHMC IRB# 04-2-31
Type: Drug trial
Enrollment: Enrollment anticipated to begin July 2004.  3-5 year study of a treatment for chronic hepatitis C virus in pediatric patients ages 5-18.  Patients must not have received prior treatment with interferon or ribavirin.

A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to <18) with Chronic Hepatitis B
CCHMC IRB# 04-3-73
Type: Drug trial
Enrollment closed.

Administration of NTBC to Patients with Tyrosinemia
CCHMC IRB# 01-4-1
Type: Database
Enrollment: Enrollment open to patients who are anticipated to receive long term therapy with NTBC (nitisinone) for tyrosinemia.

Michael D. Bates, MD, PhD

Defects of Digestive System Structure/Function: Molecular Genetic Studies
CCHMC IRB# 05-08-05
Type: Genetic study
Enrollment: Patients with congenital malformations of the digestive system, such as anorectal malformations, as well as their parents; additional family members if there is more than one affected individual in the family.

Jorge Bezerra, MD

Discarded Liver Tissue for Basic Science Research
CCHMC IRB# 01-7-15
Type: Unused tissue
Enrollment: Unused tissue collected following reduced size liver transplant.

Inflammatory Profile of Mononuclear Cells in Children with Jaundice
CCHMC IRB# 02-12-36
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 #05-04-02
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.

John C. Bucuvalas, MD

Studies in Pediatric Liver Transplant (SPLIT)
CCHMC IRB# 96-5-12
Type: Observational national registry
Enrollment: Any patient <18 years old receiving a liver transplant

A Prospective Database of Infants with Cholestasis
CCHMC IRB# 04-3-41
Type: Observational database
Enrollment: All infants <180 days of age who present with cholestasis (conjugated bilirubin > 2 mg/dL) for diagnostic work-up

Quality of Life after Liver Transplantation
CCHMC IRB# 02-11-2
Type: Parent questionnaire
Enrollment: Any liver transplant recipient <18 years of age who is 2 years post-transplant

Lee A. Denson, MD

Mechanisms of Growth Hormone Resistance in Colitis
CCHMC IRB# 04-1-10
Type: Tissue, blood
Enrollment: All patients (ages 5-16) undergoing diagnostic colonoscopy to rule out colitis.  May also involve 1 visit to the Clinical Research Center to include DEXA scan and blood draw.

A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
CCHMC IRB# 04-12-06
Type: Drug trial
Enrollment: Active Crohns disease, ages 5-18.

James E. Heubi, MD

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.

Antiresorptive Therapy for Osteopenia Associated with Chronically Immobilized Children and Adults
CCHMC IRB# 01-4-16
Enrollment: Children and adults age 6-45 with cerebral palsy and other conditions that do not allow the individual to walk.  Subjects must not have had placement of spinal rods.

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.

Michael Konikoff, MD (clinical fellow), with Marc E. Rothenberg, MD, PhD (Allergy and Clinical Immunology)

Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis: A Prospective, Randomized, Placebo-Controlled Trial
CCHMC IRB# 02-9-9
Type: Therapy trial
Enrollment: Patients age 3-21 with newly diagnosed eosinophilic esophagitis.

M. Susan Moyer, MD

IBD Registry
CCHMC IRB# 03-9-83
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.

IBD Registry: Serologic and Genetic Substudy
CCHMC IRB# 03-09-85
Type:  Blood
Enrollment: Patients up to age 16 who have newly diagnosed inflammatory bowel disease.  Study involves a one-time blood sample to identify and characterize the gene(s) that might be responsible for the development of IBD.

Nada Yazigi, MD

A Multi-Center Group Study of Acute Liver Failure
CCHMC IRB# 99-12-18
Type: Observational
Enrollment:  All patients with acute liver failure.  Study ends at discharge or transplant.