Active — Not RecruitingNot Applicable

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

Italy254 participantsStarted 2024-02-29

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition

Timeframe: 24 month

Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis

Timeframe: 24 month

Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization

Timeframe: 24 month

Trial details

NCT IDNCT06777251

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Intestinal Failure trials