Ireland
--:--IST
Recruiting Observational

Pancreatitis - Microbiome as Predictor of Severity II

NCT06508502 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2024-05-01
Last updated
2025-07-15

Condition(s) studied

Acute PancreatitisAcute Pancreatitis With Infected Necrosis

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Novel microbiome species and/or functional metabolic pathways that are associated with the severity of acute pancreatitis — until discharge (up to 90 days)
    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.
  • Classifier developed based on differentially regulated metabolites — Until discharge (up to 90 days)
    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.

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Goettingen Göttingen Lower Saxony Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06508502 on ClinicalTrials.gov ↗ ← All trials in Germany