Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Intestinal Failure; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT06777251

5483

Details and patient eligibility

About

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.

Full 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.

Enrollment: 254 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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254 participants in 1 patient group

Investigation of predictive factors in patients with intestinal failure in crohn disease

Other group

Description:

* 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.

Treatment:

Other: analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters