Monitoring patients with inflammatory bowel diseases in Emilia-Romagna
The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
This study looks at people with inflammatory bowel diseases to see what factors might lead to more serious health issues and how medications and surgeries affect their quality of life over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06721767 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance understanding of inflammatory bowel diseases (IBD) by identifying predictive factors for aggressive disease progression, frailty, surgical needs, and post-surgical outcomes. It will also assess drug safety and quality of life related to medications and surgery. Data will be collected over a 10-year period using electronic Case Report Forms, with analyses conducted using descriptive statistics and multivariate models to evaluate risk factors and event incidences.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 14 with a diagnosis of inflammatory bowel disease who have received care at the Regional Reference Center for IBD.
Not a fit: Patients who do not have a diagnosis of inflammatory bowel disease or have not received treatment at the specified center may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and outcomes for patients with inflammatory bowel diseases.
How similar studies have performed: While this study is observational and builds on existing knowledge, similar studies have shown success in identifying risk factors and improving patient outcomes in IBD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age \> 14 years * Diagnosis of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Microscopic Colitis) according to ECCO guidelines * Having undergone at least one outpatient visit and/or hospitalization at the Regional Reference Center for IBD "Massimo Campieri" * Acquisition of written informed consent from the patient and/or both parents/legal guardian Exclusion Criteria: \- None
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Fernando Rizzello, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Fernando Rizzello, MD
- Email: fernando.rizzello@unibo.it
- Phone: +39 0512145312
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.