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

NCT06777251 | Active Not Recruiting

• 1 other identifier: 5483
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Failure; Inflammatory Bowel Diseases; Crohn Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 month

Study Arms (1)

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

OTHER

* 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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Intestinal Failure; Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Alfredo Papa, MD

  Fondazione Policlinico A. Gemelli IRCCS, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: January 15, 2025
• Study Start: February 29, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 18, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

IT (1)