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

NCT06777251 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-03-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Alfredo Papa, MD · Fondazione Policlinico A. Gemelli IRCCS, Rome

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-28
Completion
2025-05-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777251 on ClinicalTrials.gov