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

Not Applicable

Active, not recruiting

• Conditions: Intestinal Failure; Inflammatory Bowel Diseases; Crohn Disease

• Registration Number: NCT06777251
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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 Timeline

• Study First Submitted: 2023-03-14
• Study Start: 2024-02-29
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Primary Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Study Completion: 2025-05-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy