Cohorts

The PREDICTS Study is a retrospective cohort drawing from an active-duty US military personnel population with relevant inclusion criteria. This study utilizes associated pre-disease and a single disease-associated archived serum samples to assess novel biomarkers with the goal of identifying pre-disease signals. The cohort is uniquely positioned for this work with access to thousands of longitudinal samples collected over 6+ years, making possible time trajectory analysis of biomarkers. The consortium’s structure of academic, industry and governmental organization investigators facilitates cross-collaboration and furthers the investigation into the trigger events, pathogenesis and potential for early detection and treatment of IBD. The goals being to predict disease risk, provide evidence to outline the early stages of the disease process and identify relevant novel exposures.


The GEM Project: Core Cohort

Since 2008, the Crohn’s Colitis Canada, Genetics, Environmental, Microbial (GEM) Project led by Dr. Croitoru has enrolled over 5,000 healthy first-degree relatives of Crohn’s disease patients from more than 100 recruitment sites globally. These participants provided blood, stool, and urine samples, along with dietary assessments, and environmental and health questionnaires at the time of enrollment. As of January 2024, 120 participants from the GEM cohort developed Crohn’s disease. The samples collected before disease onset offers an unparalleled opportunity to investigate the determinants of Crohn’s disease susceptibility. Recent discoveries within the GEM Project have unveiled that bacterial signatures, increased gut permeability, metabolomic, and proteomic profiles contribute to an increased risk to develop Crohn’s disease. Overall, the GEM project has begun to explore patterns indicative of gut bacteria potentially triggering Crohn’s disease. These finding will help develop strategies to prevent disease for those at heightened risk and possibly lead to improved treatments for individuals with established disease.


Nurses’ Health Study: Core Cohort

The Nurses’ Health Study (NHS), Nurses’ Health Study II (NHSII), and Health Professionals Follow-up Study (HPFS) are ongoing prospective cohorts of over 275,000 men and women employed as nurses or other healthcare professionals. Over 81,000 participants have provided at least one blood sample, with NHS and NHSII collecting blood at multiple time points. Follow-up questionnaires collect data on smoking, weight/height, medical history, medication use, food frequency questionnaire (FFQ), and physical activity. Incident cases of Crohn’s Disease have been reported by participants and confirmed through medical record review. The studies’ unique strengths, including regular follow-up of study participants since 1976 and repeated assessment of health and lifestyle factors, have allowed them to play an instrumental role in shaping public health recommendations.  


The MECONIUM Study aims to compare the bacterial profiles of pregnant women with and without inflammatory bowel disease (IBD) and their newborn babies. The goal is to explore the role of genetic make-up, disease activity throughout pregnancy, medications and clinical features on the bacterial composition of the baby. In addition, we will assess if feeding behavior (breastfeeding versus formula) and/or antibiotic use early in life help modify the microbiome. Given that the maternal gut bacteria can be manipulated by diet, food supplementation, and other ways, our study can help identify the types of bacteria that need to be altered prior to or during pregnancy to significantly reduce the risk of IBD transmission. You can read more about our study here.


The Road to Prevention Program (RTP) at Mount Sinai encompasses multiple projects that individually and synergistically explore the concept of life before IBD. Our central hypothesis is that a pre-clinical and overt disease state in IBD is preceded by a period of dysbiosis and immune dysregulation that can be studied by targeting high risk populations for disease development. Having a first-degree relative affected by IBD also increases risk for the development of IBD, especially for those with earlier disease onset. RTP at Mount Sinai focuses on individuals at high risk for developing IBD with the ultimate goal of this program being to identify biomarkers of disease risk from assays of genetics, serologies, and microbiome profiles of affected and unaffected members of multiplex families with IBD.