An interventional study of analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters in Intestinal Failure, Inflammatory Bowel Diseases and Crohn Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 254 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Typing of gut microbiota, metabolome and immunological signatures (IL 1b family and GLP-2 as starting point) in patients with CD and SBS/IF and in two cohorts of patients with CD, respectively at low and high risk of SBS /IF. * Combining data from gut microbiota, metabolome and immunological analysis using tools based on Artificial Intelligence (AI) and Machine Learning (ML) technologies. * Creation of a stool Biobank of categories of patients with Crohn's disease at high risk of SBS/IF and of patients with SBS with or without clinical symptoms of IF.
Other: 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.
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition
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.
Time frame: 24 month
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis
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.
Time frame: 24 month
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization
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.
Time frame: 24 month
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →