NCT06777251

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

Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation: Towards Innovative Predictive Factors and Therapeutic Targets.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intestinal Failure
• Inflammatory Bowel Diseases
• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-02-28
• Completion: 2025-05-18
• First posted: 2025-01-15
• Last updated: 2025-03-21

Locations

1 site across 1 country: Italy