PEDIATRIC GASTROENTEROLOGISTS & NUTRITIONISTS
Develop (Dr. Susan Baker) A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease (DEVELOP)
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.
Sucampo (Dr. Susan Baker) Efficacy and Safety of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
To assess the efficacy, safety, and pharmacokinetics (PK) of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to matching placebo BID, when administered orally for 12 weeks in pediatric subjects with functional constipation.
NIH NASH DB2 (Dr. Susan Baker) NAFLD Pediatric Database 2 (NAFLD Peds DB2)
The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies and contemporaneous biosamples, and will also invite pediatric participants from the prior NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric participants during the enrollment period.
Protect (Dr. Susan Baker) Predicting Response to Standardized Pediatric Colitis Therapy
This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed UC. Standardized treatments are types of treatments agreed upon and used by many qualified doctors. The medications being used in this study are considered "standard of care". Currently the ways in which these medicines are used (doses, frequency of dosing) may vary from site to site. This study will determine response to a standardized way of giving these medicines.
ProKids (Dr. Susan Baker) Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn's Disease
This is an observational prospective cohort study. The purpose of this proposal is to develop and
validate a risk stratification model for predicting severe and complicated disease phenotype in children with Crohn’s disease (CD). Demographic, clinical data together with immune, genetic and microbial (enteric flora) bio-markers in children with newly diagnosed CD will be collected. Time to develop complications (stricturing or perforating) in these patients will be documented prospectively.
Identification of the bio-markers together with prospective clinical follow up will help to identify the
estimated 20% of patients who develop severe complicated phenotype. To maximize the follow up
period to better understand the phenotype of subjects, the follow up period may be a minimum of 60 months and maximum of 120 months in any given subject.
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