Pancreatitis - Microbiome as Predictor of Severity II (NCT06508502) | Clinical Trial Compass
RecruitingNot Applicable
Pancreatitis - Microbiome as Predictor of Severity II
Germany700 participantsStarted 2024-05-01
Plain-language summary
The goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. The main questions it aims to answer are:
* Can the orointestinal microbiome robustly predict the course of acute pancreatitis?
* How does the microbiome impact the severity of an acute pancreatitis?
Buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.
Who can participate
Age range
18 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:
* Patients with initial diagnosis (\< 48h) of acute pancreatitis
* Age ≥ 18 years
* Patients able to understand/ give their written consent
Exclusion Criteria:
* Recurrent acute pancreatitis (\>2 previous episodes)
* Clinical or imaging signs of chronic pancreatitis
* Referred patients with length of hospital stay \> 48h
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
Novel microbiome species and/or functional metabolic pathways that are associated with the severity of acute pancreatitis
Timeframe: until discharge (up to 90 days)
2
Classifier developed based on differentially regulated metabolites