45 patients with CD
25 patients with UC
31 healthy subjects
54 patients with CD (34 active and 20 in remission)
79 patients with UC (30 active and 49 in remission)
22 active patients with CD and UC
319 patients with CD and UC
CD, Crohn’s disease; UC, Ulcerative Colitic
There is the need for non-invasive tests that significantly correlate with the endoscopic activity for the monitoring of IBD.
RAID-Monitor is a patented non-invasive system that offers precise monitoring of the activity status of Crohn’s disease and Ulcerative Colitis by determining a specific microbial signature in the stool sample. The diagnostic capacity of the test is significantly correlated with the endoscopic activity of these patients, offering a more effective alternative than the current available tests and allowing to reduce the number of colonoscopies performed for the monitoring of IBD.
The definition of the microbiologic signature bases on the study of 101 intestinal biopsies from patients with IBD and healthy subjects, the comparison of which has enabled the identification of a differential signature in patients with active disease. Identifying these microorganisms in the intestinal mucosa is a key point since it is more stable and resilient against external factors such as diet. The latter allows to avoid variations in the determination and to cover multiple populations with different habits. This first study has been carried out at the Hospital Universitari de Girona Dr. Josep Trueta in collaboration with the Universitat de Girona and the Institut d’Investigació Biomèdica de Girona (IdIBGi).
The next step to offer a non-invasive test for activity monitoring has been to optimize the detection in feces of this microbial signature defined in the intestinal mucosa. For this, a multicenter study has been conducted with a total of 133 fecal samples from patients with Crohn’s disease and Ulcerative Colitis, knowing their disease status. National reference hospitals participated: Hospital Universitari de Girona Dr.Josep Trueta, the Hospital Universitari de Bellvitge, the Institut d’Assistència Sanitària (IAS), and the Hospital Universitari Germans Trias i Pujol. For more information, you can consult the published results from the study here (Amoedo J, et al. 2019).
To validate that the results from the proof of concept can be extrapolated to other populations with different habits, we conducted a pilot study with 22 American patients from the Beth Israel Deaconess Medical Center in Boston (USA), in which no significant differences were observed in the diagnostic capacity of RAID-Monitor. Moreover, there is an ongoing validation in an external cohort to recruit a minimum of 319 subjects with Crohn’s Disease and Ulcerative Colitis. The study is conducted in collaboration with the Hospital Universitari de Girona Dr. Josep Trueta, the Institut d’Assistència Sanitària (IAS), the Hospital Universitari de Bellvitge, the Hospital Universitari Germans Trias I Pujol, and the Hospital General de Granollers.
RAID-Monitor will be on the market for subjects at legal age diagnosed with Crohn’s disease or Ulcerative Colitis who want to know the activity status of their disease. With our research, we want to improve the quality of life of patients by offering a fast, comfortable, and precise monitoring of their disease.