Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation: Towards Innovative Predictive Factors and Therapeutic Targets.
Status: Active_not_recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Time Frame
Start Date: 2024-02-29
Completion Date: 2025-05-18
Participants
Target number of participants: 254
Treatments
Other: Investigation of predictive factors in patients with intestinal failure in crohn disease
* 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.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS