Pancreatitis - Microbiome as Predictor of Severity II
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with initial diagnosis (< 48h) of acute pancreatitis
Age ≥ 18 years
Patients able to understand/ give their written consent
Disqualifiers
Recurrent acute pancreatitis (>2 previous episodes)
Clinical or imaging signs of chronic pancreatitis
Referred patients with length of hospital stay > 48h
Trial population
Patients with acute pancreatitis within 48h after hospital admission. Acute pancreatitis is defined if 2 of the following criteria are fullfilled. 1. Lipase \> 3x the upper limit 2. Typical abdominal pain (belt-like upper abdominal pain) 3. Characteristic CT findings
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
700 Participants
are grouped into 3 trial groupsGroup A: Revised Atlanta classifiaction (RAC) I - mild
Group B: Revised Atlanta classifiaction (RAC) II - moderate severe
Group C: Revised Atlanta classifiaction (RAC) III - severe
Trial outcomes
Primary outcomes
1
Novel microbiome species and/or functional metabolic pathways that are associated with the severity of acute pancreatitis
To assess the microbial diversity and differential abundances of species within buccal and rectal swabs analyzed by ONT sequencing followed by prediction of metabolic pathways and metabolites using tools such as Megan6 and GapSeq stratified by the Revised Atlanta Classification and severity (necrotic collections that require intervention and/or organ failure \>48h), adjusted for multiple individual confounders.
Time frame
until discharge (up to 90 days)2
Classifier developed based on differentially regulated metabolites
To assess the metabolite (predicted in 1. Primary endpoint) levels in stool and plasma samples by targeted metabolomics to develop a classifier based on differentially regulated metabolites to assess its discriminatory power in predicting Revised Atlanta Classification and severity.
Time frame
Until discharge (up to 90 days)Secondary outcomes
1
Mortality
Association of mortality with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).
Time frame
up to 1096 days (3 years)2
Length of hospital stay
Association of length of hospital stay with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder.
Time frame
up to 90 days3
Post-discharge exocrine and endocrine insufficiency
Association of post-discharge exocrine and endocrine insufficiency with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).
Time frame
up to 90 days4
Post-discharge re-intervention
Association of post-discharge re-intervention with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).
Time frame
up to 1096 days (3 years)Sponsors and contacts
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Source ClinicalTrials.gov