Gastroenterology Clinical Studies

Some of the many research opportunities available in Gastroenterology are listed below. Select a study to review a brief description and requirements. Parents or guardians of children who might be eligible are encouraged to inquire about enrollment. Contact information is listed at the end of each study.

Thank you for exploring these opportunities and helping us to find cures and prevent childhood disease.

Clinical Studies

Researchers

Alagille Syndrome and LUM001: The IMAGINE Study – Phase II

Long-term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects with Alagille Syndrome

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Alpha-1 Antitrypsin Deficiency Study – Phase II

A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1-Antitrypsin Deficiency

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Biliary Atresia IVIG Infusion Following Kasai: The PRIME Study – Phase I/IIa

Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants with Biliary Atresia

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Biliary Atresia Long-Term Observation: The BASIC Study

Biliary Atresia Study in Infants, Children and Adults

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Cholestasis Long-term Observation: The LOGIC Study

Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)

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Cholestasis Natural History Database: The PROBE Study

A Prospective Database of Infants with Cholestasis

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Colon Cleansing with Prepopik Before Colonoscopy – Phases I & II

Study Comparing the Safety and Efficacy of Prepopik versus Polyethylene Glycol Preparation in Children

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Constipation in Patients with IBS Treated with Linaclotide – Phase II

Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 7 to 17 Years with Irritable Bowel Syndrome with Constipation

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Constipation Treatment with Linaclotide – Phase II

Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

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Crohn’s Disease - Risk and Microbial Marker Study

Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease

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Crohn’s Disease and Sleep Disturbance Study – Phase IV

Treating Disrupted Sleep in Individuals with Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness

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Crohn's Disease Treatment using Blood Stem Cells – Phase I/II

Autologous Stem Cell Transplantation with CD34 Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Young Adult Patients with Severe Crohn's Disease

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IBD and Biopsychosocial Effects

Understanding the Biopsychosocial Underpinnings of Abdominal Pain in Inflammatory Bowel Disease

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IBD Registry for Pediatric Patients

Understanding the Biopsychosocial Underpinnings of Abdominal Pain in Inflammatory Bowel Disease

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IBD Treatment with Remicade®: The ADAPT Study – Phase IV

Study of Infliximab in Pediatric Participants with Inflammatory Bowel Disease (ADAPT)

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ICARE Research Registry

Intestinal Care and Rehabilitation Center Database

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Intrahepatic Cholestasis and LUM001: The INDIGO Study – Phase II

Efficacy and Long-term Safety of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in the Treatment of Cholestatic Liver Disease in Pediatric Patients with Progressive Familial Intrahepatic Cholestasis

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Mitochondrial Hepatopathies Long-term Observation: The MITOHEP Study

Longitudinal Study of Mitochondrial Hepatopathies

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Newborn Lipase Fat Digestion Study

Molecular Mechanisms of Dietary Fat Digestion by Pancreatic Lipases – Fecal Fat and Duodenal Fluid Collection Research Studies

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Pancreatitis INSPPIRE Registry

A Study of Acute Recurrent and Chronic Pancreatitis in Children by the International Study Group of Pediatric Pancreatitis In Search of a Cure (INSPPIRE)

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Primary Sclerosing Cholangitis Drug Study – Phase I

Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/ Reinstitution Trial

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TPN-Related Cholestasis Treatment with Omegaven - Phase II

Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition-Associated Hepatic Injury

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Ulcerative Colitis PROTECT Study – Phase IV

Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study

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Mark E Lowe, MD, PhD

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Feras Tawfiq Alissa, MD

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Arjumand Ghazi, PhD

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David J Keljo, MD, PhD

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Robert H. Squires, MD

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Eva M Szigethy, MD, PhD

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