Understanding difficult-to-treat inflammatory bowel disease
Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease: Multicenter Retrospective Study
This study looks at how common difficult-to-treat inflammatory bowel disease is among adults with Crohn's disease or ulcerative colitis and what factors might make it harder to manage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 972 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06551194 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and risk factors associated with difficult-to-treat inflammatory bowel disease (DTT-IBD) among adult patients diagnosed with Crohn's disease or ulcerative colitis. It utilizes a multicentre retrospective cross-sectional approach, focusing on patients who have had at least one visit with a gastroenterology specialist since January 2019. The study is guided by the recent criteria established by the International Organisation for the Study of IBD, which defines DTT-IBD based on treatment failures and other clinical complexities. By identifying the prevalence and demographic variables affecting DTT-IBD, the study seeks to inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older diagnosed with Crohn's disease, ulcerative colitis, or undetermined inflammatory bowel disease.
Not a fit: Patients with unconfirmed diagnoses of inflammatory bowel disease or those under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management strategies for patients with difficult-to-treat inflammatory bowel disease.
How similar studies have performed: While the study addresses a recent definition of DTT-IBD, similar studies have shown success in identifying treatment-resistant patient populations, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Tommaso Lo Parigi, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Tommaso Lo Parigi, MD
- Email: parigi.tommaso@hsr.it
- Phone: 02 2643 2756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.