IBD - Inflammatory Bowel DiseaseNCT06721767
Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- IBD - Inflammatory Bowel Disease
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to 1 Jul 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Fernando Rizzello, MD, +390512145312, fernando.rizzello@unibo.it
Fernando Rizzello, MD
About this study
Official title: The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
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.
Read the detailed description
The total duration of the study is expected to be 10 years. Partial analyses will be conducted during the study for data publication. The clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the Principal Investigator in an electronic Case Report Form (CRF).
Analysis Methodology:
Descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. Continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. Discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies.
To study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and Odds Ratios with 95% confidence intervals (OR - CI 95%) will be calculated.
The calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (CI 95%). Analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities.
Data will be processed using IBM SPSS statistical software (version 25.0).
- Conditions
- IBD - Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline; through study completion, an average of 8 year
Percentage of patients with the development of comorbidities.
Presence or absence of other comorbidities.
Measured: Baseline; through study completion, an average of 8 year
Percentage of patients with extraintestinal manifestations (EIMs).
Presence or absence of extraintestinal manifestations.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline; through study completion, an average of 8 year
Secondary outcomes (5)
Percentage of patients with an adverse drug reaction.
Occurrence of adverse drug reactions classified by:
- Type of adverse drug event
- Severity of the adverse event according to CTCAE 5.0
Measured: Baseline; through study completion, an average of 8 year
IBD-Q score
Inflammatory Bowel Disease - Questionnaire (validated questionnaire).
Measured: Baseline; through study completion, an average of 8 year
Percentage of gastrointestinal and non-gastrointestinal infections.
Assessment of the presence or absence of infections, including the type of infection/etiology if available, diagnosed through specific serology or culture tests.
Measured: Baseline; through study completion, an average of 8 year
Overall survival (OS) after the diagnosis of neoplastic/infectious disease.
Days elapsed between the date of diagnosis of neoplasia/infection and the date of death.
Measured: Baseline; through study completion, an average of 8 year
Evaluation of the ergonomics of the tool and its data analysis performance.
Introduction of a specific VAS scale for evaluating performance.
Measured: Baseline; through study completion, an average of 8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start8 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Rizzello, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721767
- Sponsor's protocol ID
- OMNIA
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
- ClinicalTrials.gov ID
- NCT06721767
- Acronym / sponsor ID
- OMNIA
- Conditions
- IBD - Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Jul 2034 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The total duration of the study is expected to be 10 years. Partial analyses will be conducted during the study for data publication. The clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the Principal Investigator in an electronic Case Report Form (CRF).
Analysis Methodology:
Descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. Continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. Discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies.
To study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and Odds Ratios with 95% confidence intervals (OR - CI 95%) will be calculated.
The calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (CI 95%). Analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities.
Data will be processed using IBM SPSS statistical software (version 25.0).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with aggressive disease progression.
Time frame: Baseline; through study completion, an average of 8 year
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
Percentage of fragility patients.
Time frame: Baseline; through study completion, an average of 8 year
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)
Percentage of patients with the development of comorbidities.
Time frame: Baseline; through study completion, an average of 8 year
Presence or absence of other comorbidities.
Percentage of patients with extraintestinal manifestations (EIMs).
Time frame: Baseline; through study completion, an average of 8 year
Presence or absence of extraintestinal manifestations.
Percentage of patients who underwent surgery.
Time frame: Baseline; through study completion, an average of 8 year
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).
Percentage of patients with post-surgical complications.
Time frame: Baseline; through study completion, an average of 8 year
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
Percentage of patients with a diagnosis of neoplastic disease.
Time frame: Baseline; through study completion, an average of 8 year
Presence and typing of the neoplasm, confirmed by instrumental/radiological findings and histological verification.
Percentage of patients with drug resistance.
Time frame: Baseline; through study completion, an average of 8 year
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.
5 secondary outcomes
Percentage of patients with an adverse drug reaction.
Time frame: Baseline; through study completion, an average of 8 year
IBD-Q score
Time frame: Baseline; through study completion, an average of 8 year
Percentage of gastrointestinal and non-gastrointestinal infections.
Time frame: Baseline; through study completion, an average of 8 year
Overall survival (OS) after the diagnosis of neoplastic/infectious disease.
Time frame: Baseline; through study completion, an average of 8 year
Evaluation of the ergonomics of the tool and its data analysis performance.
Time frame: Baseline; through study completion, an average of 8 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Rizzello, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Rizzello, MD (+39 0512145312, fernando.rizzello@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with aggressive disease progression. (time frame: Baseline; through study completion, an average of 8 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.