The Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) is dedicated to improving the lives of individuals with eosinophilic
gastrointestinal disorders through innovative research, clinical expertise and education via collaborations between scientists, health care providers,
patients, and professional organizations. The disorders CEGIR focuses on are eosinophilic esophagitis (EoE), eosinophilic gastritis (EG) and eosinophilic
colitis (EC). The team has a multidisciplinary approach and integrates expertise in pediatric and adult clinical specialties, including gastroenterology,
allergy, immunology and pathology. Funded by the National Institutes of Health (NIH), CEGIR is part of the Rare Diseases Clinical Research Network (RDCRN).
CEGIR has four primary cores: Clinical Research Projects 1 and 2, a Pilot/Demonstration Clinical Research Program, and the Training (Career Development)
Program. There is also an Administrative Core that directs and coordinates the activities of these endeavors.
Clinical Research Project 1, called the OMEGA Trial (Outcome Measures for Eosinophilic Gastrointestinal Diseases Across Ages),
is a multicenter, longitudinal study of children and adults with EoE, EG and EC focused on two aims. Aim 1 is to determine the correlation of
clinical outcome measures (COMs), including patient-reported outcomes (PROs), with the histological disease activity as measured by mucosal eosinophil
counts. We will also test a series of related hypotheses concerning secondary histological parameters that may correlate with clinical and phenotypic
measurements, potentially leading to a new gold standard for EoE, EG, and/or EC diagnosis and monitoring. Aim 2 is to determine the correlation of
the molecular profile for EoE, EG, and EC with COMs and mucosal eosinophilia. We will identify biopsy-based mRNA expression profiles of children and adults
with EoE, EG, and EC from Aim 1 in order to identify disease-specific molecular diagnostic criteria, provide key insight into disease pathogenesis, and
answer questions concerning the molecular basis of distinct clinical phenotypes.
Clinical Research Project 2, called the SOFEED Trial (Six Versus One Food Eosinophilic Esophagitis Diet),
is a multicenter study with two aims. Aim 1 is to conduct a randomized diet trial that eliminates one food (milk) vs. six foods (milk, egg, wheat,
soy, nuts and fish) to evaluate the efficacy of less restricted diets and determine whether patients who experience diet failure remain responsive to
swallowed glucocorticoids (SGC) therapy if they fail the 6FED and remain responsive to 6FED when they fail 1FED. Aim 2 is to develop a
personalized medicine approach based on biomarker analysis that can predict the best treatment for individual patients. Clinical Research Project 2
addresses a topic of direct interest to patient advocacy groups (PAGs) and their constituents – the rapid development of practical solutions for
individuals living with EoE. We aim to optimize treatment with readily available therapies (diet and SGCs) and develop a personalized medicine approach,
based on cutting-edge biomarker analysis, to optimize response rates and reduce unnecessary treatments and procedures.
The Pilot/Demonstration Clinical Research Program supports new ideas that have potential to create and/or change paradigms concerning
EoE, EG, and EC. We support up to two Pilot/Demonstration Clinical Research
Projects each year. The Projects last up to two years and ideally take maximum advantage of new clinical research opportunities in investigating EoE, EG,
and EC. The projects are collaborative among investigators within one or more CEGIR sites or with investigators outside the CEGIR environment. Projects
are selected by their likelihood to develop new models and ideas that will improve the way researchers, healthcare providers, and patients understand these
diseases and to develop better treatments.
The Training (Career Development) Program trains new investigators in clinical and translational research, enhancing the likelihood of
academic success for the investigators in training. The program’s specific goals are: 1) to enable CEGIR Trainees to become independent clinical and/or
translational investigators; 2) to aid CEGIR Trainees in developing a broad understanding of the basic, translational, and clinical science pertinent to
the immunobiology, pathogenesis, and genetics of EoE, EG, and EC via didactic instruction; and 3) to facilitate CEGIR Trainee networking and integration in
the EoE, EG, and EC research community. It is our belief that increasing the number and quality of clinician researchers studying EoE, EG, and EC will
improve current and future patient care.
Patient Advocacy Groups
(PAGs) are an important part of the CEGIR team. PAGs contribute numerous resources to the consortium, including, but not limited to: efficient pathways to
communicate the latest clinical and research developments to patients and their families (via conferences, websites, newsletters, contact registries); a
forum for the collection and dissemination of patient and family perspectives and priorities; public educational initiatives to raise awareness of and
quality of care for eosinophilic GI diseases; and financial support for important research and clinical efforts.
We welcome partnership with
industry, including conducting clinical trials.