Ongoing Clinical Trials

PMAPS - Pancreatitis – Microbiome As Predictor of Severity

A prospective multicentre translational study

This trial is registered on clinicaltrials.gov: NCT04777812

PI: Albrecht Neesse, MD, PhD

Gastroenterology, Gastrointestinal Oncology and Endocrinology

University Medical Centre Göttingen, Germany

Study details 

Hypothesis: The orointestinal microbiome may be utilized as early biomarkers for the severity and course of AP

Enrollment:

• Inclusion criteria: Patients with acute pancreatitis, hospital stay < 72h
• Exclusion criteria: Pregnancy, age <18 years
• Primary endpoint: Association of revised Atlanta classification with microbiome patterns
• Secondary endpoints: Length of hospital stay, mortality, number of interventions

Clinical samples:

• Microbiome of buccal and rectal swabs (non-invasive)
• Clinical data will be collected with a standardized online questionnaire
• Swab tubes will be provided, shipment costs will be paid
• Translated study protocol, patient consent forms and ethical approvals for EU-Hospitals available

Sequencing platform in Göttingen, Germany:

• DNA extraction with established protocols conform with International Human Microbiome Standards (IHMS)
• Metagenomic analysis with Oxford Nanopore Technology (ONT)
• Established Bioinformatics Pipeline

Kindly note that this trial has reached the required number of participating centers.

For general questions, please contact:

Principal investigator: Prof. Albrecht Neesse

albrecht.neesse@med.uni-goettingen.de

Study coordinator: Dr. Christoph Ammer-Herrmenau

christoph.herrmenau@med.uni-goettingen.de