Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL) (INT-FAIL)
Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation: Towards Innovative Predictive Factors and Therapeutic Targets.
Study Overview
Status
Detailed Description
The study involves an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsy (additional biopsy collection at the same time as clinical practice biopsy for study-specific analysis) will be performed.
Patients will then be re-evaluated nine months after the initial evaluation. In particular, faecal, blood and additional biopsy samples will be collected at the same time as the clinical practice biopsy and any changes in treatment will be recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years-old and ≤ 75 years old
- Capable of expressing informed consent;
- An established diagnosis of Crohn's disease;
- Antibiotics treatment free for at least 15 days.
Exclusion Criteria:
- Age < 18 years-old and > 75 years old;
- Not capable of expressing informed consent;
- Pregnant or breastfeeding patients;
- Comorbidities including: cancer pathology present or under active treatment; coagulopathies; chronic hepatopathy, heart failure, renal failure, respiratory failure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Investigation of predictive factors in patients with intestinal failure in crohn disease
|
The study includes an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsies will be performed (additional biopsy in conjunction with a biopsy from clinical practice for study-specific analyses). Patients will then be reevaluated nine months after the initial evaluation. In particular, fecal, blood and additional biopsy samples will be collected in conjunction with clinical practice biopsy and all treatment modifications will be recorded. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition
Time Frame: 24 month
|
This section focuses on characterizing the gut microbiota composition in patients with Crohn's disease at risk of SBS/IF. Advanced sequencing technologies and bioinformatics tools will be used to analyze the relative abundance of microbial species associated with SBS/IF risks. Unit of Measure: percentage or relative abundance of microbial taxa. Objective: To identify microbiota profiles predictive of dysbiosis and their association with SBS/IF risk factors. |
24 month
|
|
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis
Time Frame: 24 month
|
This section emphasizes the analysis of metabolic profiles. Key metabolites associated with SBS/IF risk will be quantified using mass spectrometry and other advanced chemical analysis techniques. Unit of Measure: metabolite concentration (e.g., µM, mM). Objective: To understand how metabolic variations influence the development of SBS/IF and support the design of targeted nutritional interventions. |
24 month
|
|
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization
Time Frame: 24 month
|
This section investigates the characterization of immunological biomarkers. Specific levels of the IL-1β family and GLP-2 will be measured as indicators of immune response and intestinal repair mechanisms. Unit of Measure: concentration (pg/mL). Objective: To identify immunological signatures associated with an increased risk of SBS/IF and optimize biomarker-based therapeutic strategies. |
24 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alfredo Papa, MD, Fondazione Policlinico A. Gemelli IRCCS, Rome
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5483
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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