Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

NCT06721767 | Recruiting

• 1 other identifier: OMNIA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. Specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.

Conditions

IBD - Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (8)

• Percentage of patients with aggressive disease progression.

  Occurrence, at least once during the natural history of the patient's disease, of one or more characteristics of aggressiveness, namely: * Immunosuppressive/biotechnology/small molecule therapy due to failure of conventional therapy or severe disease * Surgery due to failure of medical therapy or the onset of complications such as strictures or fistulas * Endoscopic recurrence of disease post-surgery * Hospitalization for severe disease or the onset of complications

  Baseline; through study completion, an average of 8 year

• Percentage of fragility patients.

  Presence of one or more characteristics of frailty, namely: * Polypharmacy (defined as the need to take at least one other medication for a condition other than inflammatory bowel disease) * Short bowel syndrome post-surgery (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) requiring supplemental enteral/parenteral nutrition * Osteoporosis (defined as bone mineral density - BMD - with a T-score less than -2.5) with or without pathological fractures * One or more extraintestinal manifestations (EIMs)

  Baseline; through study completion, an average of 8 year

• Percentage of patients with the development of comorbidities.

  Presence or absence of other comorbidities.

  Baseline; through study completion, an average of 8 year

• Percentage of patients with extraintestinal manifestations (EIMs).

  Presence or absence of extraintestinal manifestations.

  Baseline; through study completion, an average of 8 year

• Percentage of patients who underwent surgery.

  Number of surgical interventions for luminal disease (defined as disease affecting one or more segments of the gastrointestinal tract). Number of surgical interventions for perianal disease (defined as the presence of perianal fistulas, abscesses, ulcers, and anal strictures).

  Baseline; through study completion, an average of 8 year

• Percentage of patients with post-surgical complications.

  Presence of one or more of the following elements: * Early complication (\< 30 days) or late complication (\> 30 days) post-surgery * Development of short bowel syndrome (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) post-surgery (if Crohn's disease) * Need for major therapy post-surgery

  Baseline; through study completion, an average of 8 year

• Percentage of patients with a diagnosis of neoplastic disease.

  Presence and typing of the neoplasm, confirmed by instrumental/radiological findings and histological verification.

  Baseline; through study completion, an average of 8 year

• Percentage of patients with drug resistance.

  Failure: * Primary * Secondary * Primary failure refers to the lack of efficacy after the induction phase, while secondary failure refers to the loss of efficacy after initial benefit.

  Baseline; through study completion, an average of 8 year

Secondary Outcomes (5)

• Percentage of patients with an adverse drug reaction.

  Baseline; through study completion, an average of 8 year

• IBD-Q score

  Baseline; through study completion, an average of 8 year

• Percentage of gastrointestinal and non-gastrointestinal infections.

  Baseline; through study completion, an average of 8 year

• Overall survival (OS) after the diagnosis of neoplastic/infectious disease.

  Baseline; through study completion, an average of 8 year

• Evaluation of the ergonomics of the tool and its data analysis performance.

  Baseline; through study completion, an average of 8 year

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of adult patients with IBD being followed at the Regional Reference Center "Massimo Campieri," which includes the General Surgery Unit and the IBD Specialties Unit of IRCCS AOUBO for the management of intestinal and extraintestinal conditions. Enrollment will take place in the IBD Specialties Unit during follow-up outpatient visits, hospital admissions, or through a phone/email invitation conducted by staff affiliated with the Unit.

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fernando Rizzello, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Rizzello, MD

CONTACT

+39 0512145312; fernando.rizzello@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 6, 2024
• Study Start: January 8, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2034
• Last Updated: December 6, 2024

Record last verified: 2024-10

Locations

IT (1)