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 DEGAS (Dupilumab Eosinophilic Gastritis Study), is a phase 2 multicenter, randomized, double-blind, placebo controlled trial testing the efficacy of dupilumab compared to placebo, to reduce eosinophilic inflammation in the stomach of patients with EG/EGE. Dupilumab efficacy will be measured using patient-reported outcomes (PROs), with histological disease activity as measured by mucosal eosinophil counts, and with endoscopic disease activity as measured by the eosinophilic gastritis endoscopy assessment. Additionally we will identify whether there is an association with dupilumab treatment with blood and tissue biomarkers and mRNA expression profiles of children and adults with EG/EGE.
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 early stage scholars in rare eosinophilic gastrointestinal diseases (EGIDs). Through the CEGIR LEADERS (Longitudinal Enhancement And Development in Eosinophilic gastrointestinal and Rare diseases Scholarship) program, the Core is designed to enhance the likelihood of rare diseases focus and academic success of scholars in training. The program’s specific goals are: 1) attract early stage scholars to the field of rare diseases, with a focus on EGIDs; 2) help scholars gain research experiences in EGIDs; 3) enhance and encourage scholars’ career development along a rare diseases career path. 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.