Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory B
Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time. In 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common defini
| Condition(s) | Assessment of the Criteria and Risk Factors for DTT-IBD |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time. In 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common definition of 'difficult-to-treat' inflammatory bowel disease (IBD-IBD) to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies. According to the IOIBD criteria, IBD is defined by any of the following: failure of two or more advanced treatments with different mechanisms of action, postoperative recurrence of Crohn's disease after two or more bowel resections, pouchitis refractory to antibiotics, complex perianal Crohn's |
| Who can participate | Inclusion Criteria: * Adult patients (age ≥18) * Diagnosis of IBD: Crohn's disease (CD), ulcerative colitis (UC), or undetermined IBD (IBD-U) * A least one visit with a gastroenterology specialist after 01/01/2019 Exclusion Criteria: * Unconfirmed IBD diagnosis * Consultation with non-gastroenterology specialists * Consultation older than January 1st 2019 * Pediatric patients (Age \<18). Pediatric population will be excluded as the DTT-IBD criteria apply to adult patients only. |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Lead sponsor | IRCCS Ospedale San Raffaele |
| Locations | Milan, Italy |
| Start date | 2024-06-01 |
| NCT ID | NCT06551194 |
| Official listing | https://clinicaltrials.gov/study/NCT06551194 |