Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL) (NCT06777251) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition
Timeframe: 24 month
2
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis
Timeframe: 24 month
3
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization