Research Cohorts
A research cohort study is a type of observational study in which researchers follow participants over an extended period of time, usually many years.
We recently completed one such study, the Pediatric RISK Stratification Study, which followed nearly 1000 children with Crohn’s disease from 28 clinics in the U.S. and Canada. A 10-year and $10-million-plus investment, RISK was the largest new-onset study ever completed on pediatric Crohn’s disease patients.
The study revealed that starting patients early on biologic drugs reduces the likelihood of patients developing fistulas (abnormal channels between the gut and another organ or vessel). Through this project, researchers also identified genetic and other traits that predicted which children were likely to develop serious complications. The Foundation is using these findings to develop a risk diagnostic tool that could help clinicians make therapeutic decisions about which type of medication to give to children at diagnosis.
The Foundation also completed its online registry, IBD Partners, which included than 14,000 IBD adult and pediatric patients from across the world who participated. The Foundation will be launching its new registry, MyIBD Health Study, in 2024.
Currently, we are sponsoring three ongoing cohort studies:
- SPARC IBD
- CAPTURE IBD
- IBD SIRQC
Data and biosamples collected from consenting patients participating in these studies feed into the Foundation’s IBD Plexus platform, the robust IBD research network with a linked biobank in the United States.
SPARC IBD
The Study of a Prospective Adult Research Cohort with IBD (SPARC IBD) plans to follow up to 7,000 adults with IBD and track their disease activity using biosamples including blood, stool, and intestinal cells. These samples will be used to learn more about which treatments and treatment strategies are most effective, develop new drug targets, discover new biomarkers that can be used to monitor disease, and more.
The SPARC researchers are particularly interested in finding new ways to predict who is likely to relapse, as well as identify characteristics that would help doctors match each patient to the best treatment for them - an approach known as precision medicine.
SPARC is led by co-principal investigators James Lewis, MD, of the University of Pennsylvania, and Laura Raffals, MD, of the Mayo Clinic in Minnesota. Patients enroll in SPARC IBD through their healthcare provider. There are a total of 20 participating sites across the U.S.
CAPTURE IBD
Currently, much of the care provided to children with IBD has been based on research based on adults. The Foundation identified that more pediatric-specific research is needed to develop best practices for children. Launched in September of 2020, CAPTURE IBD (Cohort for Pediatric Clinical and Translational Research in IBD) is poised to become a robust repository of data on children and young adults ages 4–21 with IBD.
CAPTURE will include children with ulcerative colitis as well as Crohn’s disease. Its ultimate goal is to advance precision medicine by matching distinct subgroups of patients to the specific therapy or therapies most likely to be effective for them.
Participants in CAPTURE will continue receiving their usual care while allowing their doctors to share detailed data about their health along with blood, stool, and tissue samples for use in the study. Researchers will then thoroughly analyze demographic, clinical, and “multi-omic” data (which includes genomics and microbiomics). The goal is to use these findings to identify specific groups of characteristics (known as biological signatures) that can help identify whether an individual child will respond well to a given type of medicine.
CAPTURE is being led by Michael Rosen, MD, of Stanford Medicine, and Stacy Kahn, MD, of Boston Children’s Hospital, with a total of 12 pediatric IBD centers participating.
IBD SIRQC
IBD SIRQC (IBD Surgical Innovation, Research, and Quality Collaborative) is the Foundation’s first-ever surgical research initiative and aims to help the 70% of people with Crohn’s disease and 30% with ulcerative colitis who will undergo at least one GI surgery during their lifetime.
IBD SIRQC will enroll adults with Crohn’s disease or ulcerative colitis preparing to have GI surgery and will follow them through their surgery and beyond to track long-term outcomes. The findings will expand our understanding of the impact of surgery on IBD, including post-procedure complications and disease recurrence. The study also aims to advance precision medicine by identifying factors that can be used to predict who is most likely to remain healthy after surgery and who will need further intervention and treatment.
IBD SIRQC is being spearheaded by Stefan Holubar, MD, at the Cleveland Clinic, and Samuel Eisenstein, MD, at UC San Diego Health. Currently, a total of 9 sites are participating across the country, with more to come soon.
MyIBD Health Study: Our New Adult Patient Registry
The Foundation is launching MyIBD Health Study in 2024 in partnership with Verily, a precision health company. The goal of the study is to create a large, diverse community of IBD patients to follow during their disease course. Patients enrolled in the registry will periodically provide feedback about their symptoms and quality of life to help researchers understand and improve the management of patient disease progression.
