Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease
NCT ID: NCT06551194
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
972 participants
OBSERVATIONAL
2024-06-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
NCT06516341
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
NCT07172945
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
NCT02508012
Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients
NCT06324591
Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Cross-sectional, Monocentric Study
NCT05719402
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
UC patients
Adult patients (age ≥18) diagnosed with UC
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
prevalence of difficult-to-treat IBD
To assess the prevalence and risk factors of difficult-to-treat IBD patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
prevalence of difficult-to-treat IBD
To assess the prevalence and risk factors of difficult-to-treat IBD patients
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
69 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Ospedale San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tommaso Lorenzo Parigi
MD Gastroenterologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tommaso Lo Parigi, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS San Raffaele
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DTT-IBD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.