Pancreatitis - Microbiome As Predictor of Severity

Study Overview
=================
Brief Summary
-----------------
This study is a multicentric prospective study initiated and coordinated from the University Medical Centre Goettingen. The study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.

Detailed Description
-----------------
This prospective translational study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis. From each patient one buccal and rectal swab is collected within 72 h after hospital admission. Microbial composition will be determined by 16S and metagenomics Oxford Nanopore Sequencing (ONT) and correlated with the revised Atlanta classification as the primary endpoint. Secondary endpoints are the correlation of microbiome signatures with the length of hospital stay, numbers of interventions and mortality. To this end, alpha and beta diversity of microbiota are determined and compared between mild, moderately severe and severe acute pancreatitis.

Official Title
-----------------
Pancreatitis - Microbiome As Predictor of Severity

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Diagnostic Test: Rectal and buccal swabs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute pancreatitis (2 out of 3 following diagnostic criteria: lipase >3x of upper limit, abdominal pain, and imaging modalities (computed tomography, magnetic resonance imaging or ultrasound). < 72 hours after hospital admission. Exclusion Criteria: Pregnant women Patients < 18 years; Patients who are incapable of giving consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Rectal and buccal swabs|The oral and intestinal flora is collected from buccal and rectal swabs.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Atlanta classification I-III | Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | days in hospital during initial admission | up to 12 months | 
| Numbers of interventions (surgical and endoscopical) | number of percutaneous drainages, number of EUS-guided interventions of infected necrotic or acute collections, type of drainages (plastic versus lumen apposing metal stents), number of open surgical interventions | up to 12 months | 
| Mortality | in hospital mortality during initial admission (%) | up to 12 months |