Project description
Inflammatory bowel disease (IBD) is a group of immune-based diseases that affect the digestive tract, causing chronic inflammatory processes. Crohn's disease (CD) and ulcerative colitis (UC) are the two most common types of IBD that evolve with flare-ups (active phase) of variable severity and duration, alternating with remissions (inactive phase) also of variable duration. However, both diseases have certain differences between them, such as genetic predisposition and risk factors, and differences at the endoscopic and histological level. Constant monitoring of the inflammatory activity of these patients is necessary to correctly adapt the therapeutic regimen. Currently, monitoring of the disease is carried out with endoscopic tests that are invasive, costly and/or involve side effects for the health of patients. However, it is important to know about endoscopic activity since its presence has been related to a poor prognosis, risk of clinical relapse and a greater need for hospitalization and surgery. In general, it is important to highlight the needs currently not covered in this type of diagnosis and monitoring and to which GoodGut aims to provide a solution within the framework of this project. Current diagnoses do not have good reliability nor allow for personalized patient monitoring.
The present project seeks to develop and validate a specific, sensitive and non-invasive kit for monitoring the activity of inflammatory bowel disease, based on the analysis of fecal microbial markers by qPCR. The achievement of this objective will allow GoodGut to have an in vitro diagnostic technology to monitor the activity of IBD more effective than those that currently exist. To do this, the following partial objectives will need to be achieved:
1. Optimization of a fecal microbial signature in patients with IBD (CD or UC) without intestinal surgery that allows monitoring of intestinal activity.
2. Definition of a fecal microbial signature in patients with Crohn's disease with intestinal surgery that allows monitoring of intestinal activity.
3. Conducting clinical performance studies to evaluate the diagnostic capacity of the fecal microbial signatures defined within the framework of the first 2 objectives, both in patients with
4. Design, development and optimization of an analytical protocol that allows the analysis of fecal microbial markers included in the specific defined signatures for monitoring activity in patients with IBD.
5. Design and development of the “ready to use” kit. This will include all the necessary reagents so that any external laboratory can perform the analysis of the defined fecal microbial signatures.
6. Writing and publication of the results obtained in the different phases of the project, in addition to carrying out dissemination activities at both national and international congresses in the field of gastroenterology and microbiology, as well as in high-impact scientific journals.
From a scientific-technical point of view, the activity to be developed will provide high value by allowing rapid and accurate monitoring of the disease. The new non-invasive test to be developed has the potential to obtain greater specificity for monitoring IBD than the tests currently in use. If a high correlation with colonic mucosal lesions is achieved, the need to perform an endoscopic examination on patients to estimate disease activity would be avoided. This would mean a better allocation of available resources and a lower economic burden associated with IBD, as well as an improvement in the quality of life of these patients.
