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Pancreatitis - Microbiome As Predictor of Severity (P-MAPS)

U

University Medical Center Goettingen

Status

Completed

Conditions

Acute Pancreatitis

Treatments

Diagnostic Test: Rectal and buccal swabs

Study type

Interventional

Funder types

Other

Identifiers

NCT04777812
P-MAPS_02794

Details and patient eligibility

About

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.

Full 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.

Enrollment

424 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Albrecht Neesse, MD, PhD

Data sourced from clinicaltrials.gov

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