Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease (DTT-IBD)

Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease: Multicenter Retrospective Study

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).

Study Overview

• Status: Recruiting
• Conditions: Assessment of the Criteria and Risk Factors for DTT-IBD
• Intervention / Treatment: Other: prevalence of difficult-to-treat IBD

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).

• Study Type: Observational
• Enrollment (Estimated): 972

Contacts and Locations

• Study Contact: Name: Tommaso Lo Parigi, MD; Phone Number: +39-022643275 02 2643 2756; Email: parigi.tommaso@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Tommaso Lo Parigi, MD; Phone Number: 0226432756; Email: parigi.tommaso@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients (≥18) diagnosed with IBD followed at San Raffaele Hospital and Humanitas Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UC patients; Adult patients (age ≥18) diagnosed with UC	Other: prevalence of difficult-to-treat IBD; To assess the prevalence and risk factors of difficult-to-treat IBD patients
CD patients; Adult patients (age ≥18) diagnosed with UC	Other: prevalence of difficult-to-treat IBD; To assess the prevalence and risk factors of difficult-to-treat IBD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBD not meeting the DTT-IBD criteria	In absence of prior literature describing the prevalence of DTT (our will be the first study) a sample size calculation can only be estimated based on clinical experience. Based on our clinical experience, assuming a Cohen effect size of 0.18, using a two-sided t-test with an alfa error of 0.05, 486 subjects in each group would be needed to detect a significant difference between the two (DTT and non-DTT). Therefore the total included population would be 486 x 2 = 972 patients.	3 months

Collaborators and Investigators

• Sponsor: IRCCS Ospedale San Raffaele
• Investigators: Principal Investigator: Tommaso Lo Parigi, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: DTT-IBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No