A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease (CD) ? CAPE Save

Date Added
June 16th, 2016
PRO Number
Pro00046546
Researcher
Jose Quiros
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

A Crohn's Disease Registry for pediatric patients (between the ages of 6 and 17 years) with moderately to severely active Crohn's Disease (CD), who are already taking Humira® (Adalimumab) to treat their condition. Data from the participant's medical record will be collected to study the long-term safety and effectiveness of Humira®. The Registry expects to collect data for 10 years. No study drug will be given.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

A Phase Ib/IIa Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates Save

Date Added
April 26th, 2016
PRO Number
Pro00048200
Researcher
Sarah Taylor
Keywords
Bowel, Digestive System, Disease Prevention, Infant, Nutrition, Pediatrics
Summary

The Sponsor is conducting a clinical study with STP206 for the prevention of Necrotizing Enterocolitis (NEC) in preterm infants weighing less than 4.4 lbs. (2000g). NEC is the most common serious disease of the gut in preterm infants. The purpose of this study is to look at the safety of STP206 in babies born early, and to get early information on whether STP206 may prevent NEC.

STP206 is an investigational product, meaning it is not yet approved by the US Food and Drug Administration for use in the United States. STP206 contains live bacteria and is considered a Live Biotherapeutic. The two types of bacteria are Lactobacillus and Bifidobacteria. These bacteria are used in foods such as cheese, yogurt, sauerkraut, and pickles, and have been consumed safely for years and are commonly contained in probiotic products that are currently sold throughout the world. These bacteria also are normally present in parts of the body such as bowel, mouth, skin, and the vagina. These bacteria generally do not cause disease. There have been studies of probiotic bacteria in premature babies that suggest these types of bacteria are effective in preventing NEC. The purpose of this study is to determine the safety of STP206 and if it is effective in preventing NEC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
792-0601
yeadon@musc.edu

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction Save

Date Added
June 16th, 2015
PRO Number
Pro00044409
Researcher
Whitney Graybill
Keywords
Bowel, Cancer
Summary

This study is for patients who have a malignant bowel obstruction and their doctor is not sure if surgery or non-surgical treatment will be better for the condition.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Gene Discoveries in Subjects with Crohn?s Disease of African Descent Save

Date Added
September 2nd, 2014
PRO Number
Pro00034427
Researcher
Jose Quiros
Keywords
Bowel, Children's Health, Crohn's Disease, Digestive System, Ethnicity and Disease, Genetics, Minorities, Pediatrics
Summary

A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children?s Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.

The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

Hirschsprung Disease Research Collaborative Save

Date Added
August 7th, 2012
PRO Number
Pro00014680
Researcher
Robert Cina
Keywords
Bowel, Genetics
Summary

Hirschsprung disease (HSCR) is a birth defect resulting from the absence of nerve (ganglion) cells in the gastrointestinal tract. Hirschsprung disease has a population incidence of 1/5000 live births and most often occurs as an isolated condition. However, approximately 30% of HSCR cases are associated with other birth defects such as Down syndrome, deafness, hypopigmentation, and Ondine?s curse (Congenital Central Hypoventilation syndrome (CCHS)). Hirschsprung disease is a genetic condition with autosomal dominant, autosomal recessive, and multigenic patterns of inheritance described. While several genes associated with HSCR have been identified, it is expected that additional genes play a role in the disorder. Furthermore, much remains to be understood about the mechanisms of genetic variants involved in the disease and how variants in multiple genes interact to lead to multiigenic forms of HSCR.

The objective of the Hirschsprung Disease Research Collaborative (HDRC) is to build a large collection of data and biological samples of individuals with HSCR by which genetic data can be linked to detailed and accurate phenotypic information about study participants. The goal of the genetic studies carried out with HDRC samples is to identify genes harboring causative HSCR mutations and to better understand the complex inheritance of HSCR in families by whole genome mapping and sequencing studies. Specifically, we intend to ascertain the frequency with which mutations in any human gene lead to familial and isolated forms of HSCR. Further, clinical information will be used to investigate possible genotype ? phenotype correlations and their relationship with medical, surgical and pathological data on patients.

Institution
MUSC
Recruitment Contact
Robert Cina
843-792-3851
cina@musc.edu

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