New England Gastropareis Consortium: Neurobiology of Gastroparesis

ABSTRACT
Gastroparesis (Gp) in children and adults is characterized by delayed gastric emptying in the absence of
mechanical obstruction. GP is associated with significant morbidity and mortality, yet little is known regarding its
incidence, prevalence, and natural history in children. This knowledge gap in pediatric Gp is exacerbated by the
overlap in symptoms and pathophysiology with functional dyspepsia (FD), a common disorder in adults and
children. The limited data suggests significant differences between clinical symptoms and pathophysiology of
Gp and FD in children vs adults. Thus, data regarding Gp and FD in adults is unlikely to provide insight and fill
the knowledge gaps regarding Gp and FD in children. These issues (among others) underscore the need for
childhood Gp- and FD-specific research strategies. Thus, the goals of this supplemental application are to build
on and extend our Pediatric Gp Registry 2 (PGpR2) work as part of the NIDDK Gastroparesis Consortium
(GpCRC) ultimately, to determine the factors contributing to disease severity measured by quality of life and
symptoms. The Specific Aims of the current project are to:
Aim 1: Create a national prospective registry of children and adolescents with gastroparesis Gp) and Gp-like
syndrome (GLS; the latter group, using pediatric Rome IV criteria will be characterized as having FD (functional
dyspepsia, including the two subtypes [FD-EPS, FD-PDS]), chronic nausea vomiting syndrome, cyclic vomiting
syndrome, and/or chronic abdominal pain syndrome to include demographic, clinical, psychological, nutritional
characteristics, physiological measures, and serial assessments of symptoms over 3 years during their clinical
care.
Aim 2: Follow this well-characterized cohort to further define the natural history, clinical course, and selected
physiologic measures of children and adolescents with symptoms of Gp.
Aim 3: Provide a reliable source for recruitment of well-characterized children and adolescents with Gp and
FD for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other
ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study
protocols with separate consent processes.
Supplement Aim: Expand the number of pediatric sites within the PGpR2 to facilitate recruitment and
consequently, the goals of the PGpR2.
This innovative multidisciplinary approach will prospectively begin to fill the vast knowledge void regarding
Gp and FD in children. The current supplement proposal is responsive to RFA-DK-20-504 and PA-20-272 by
achieving among other goals, to build on our previous gains and expand the number of pediatric sites to enhance
recruitment.

Grant Number: 3U01DK112193-09S1
NIH Institute/Center: NIH
Principal Investigator: Helen Burton Murray