Clinical trial NCT06551194: Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease
Official title: Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease: Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Assessment of the Criteria and Risk Factors for DTT-IBD
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 972
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (≥18) diagnosed with IBD followed at San Raffaele Hospital and Humanitas Hospital

Brief 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 disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.

As the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019).

Detailed description: This is a multicentre retrospective cross-sectional study with two aims:

1. To evaluate the prevalence of difficult-to-treat IBD
2. To evaluate which and how demographic and clinical variables affect the risk of DTT-IBD

The subjects considered are adult patients (≥18 years) diagnosed with UC or CD followed at San Raffaele Hospital and Humanitas Research Hospital.

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 disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.

As the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019).

Eligibility criteria: 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.

Primary outcomes:
measure: IBD not meeting the DTT-IBD criteria
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Tommaso Lo Parigi, MD
role: PRINCIPAL_INVESTIGATOR
References: