NCT04777812

Pancreatitis - Microbiome As Predictor of Severity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: University Medical Center Goettingen · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rectal and buccal swabs	The oral and intestinal flora is collected from buccal and rectal swabs.

Timeline

• Start date: 2020-02-17
• Primary completion: 2023-09-30
• Completion: 2024-02-23
• First posted: 2021-03-02
• Last updated: 2024-04-30

Locations

1 site across 1 country: Germany