analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters
analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters: 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.
Study summary
This is an interventional, prospective, no profit study that will be performed at CEMAD, from FONDAZIONE POLICLINICO GEMELLI IRCCS, Rome (UO1) and U.O.C. Internal Medicine and Gastroenterology from Ospedale Brotzu di Cagliari (UO4). Adult patients with Crohn Disease (CD) and chronic intestinal insufficiency (CF) and adult patients with CD at high and low risk of CF.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition — 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.
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis — 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.
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization — 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.
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Italy
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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