Pancreatitis - Microbiome As Predictor of Severity

Not Applicable

Completed

• Conditions: Acute Pancreatitis

• Registration Number: NCT04777812
• Lead Sponsor: University Medical Center Goettingen

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.

Study Timeline

• Study Start: 2020-02-17
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Primary Completion: 2023-09-30
• Study Completion: 2024-02-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Revised Atlanta classification I-III	up to 8 weeks	Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 12 months	days in hospital during initial admission
Mortality	up to 12 months	in hospital mortality during initial admission (%)
Numbers of interventions (surgical and endoscopical)	up to 12 months	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

Trial Locations

Locations (1)

University Medical Centre Göttingen; 🇩🇪 Göttingen, Germany