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NCT Number: NCT04777812

Pancreatitis - Microbiome As Predictor of Severity

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Göttingen

Göttingen, 37075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal and buccal swabs

Diagnostic Test

The oral and intestinal flora is collected from buccal and rectal swabs.

Primary outcomes

  1. Revised Atlanta classification I-III

    Time frame: up to 8 weeks

    Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.

Secondary outcomes

  1. Length of hospital stay

    Time frame: up to 12 months

    days in hospital during initial admission

  2. Numbers of interventions (surgical and endoscopical)

    Time frame: 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

  3. Mortality

    Time frame: up to 12 months

    in hospital mortality during initial admission (%)

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Collaborators

  • Department if Medical Statistics, University Medical Center Göttingen
  • Department of Medical Bioinformatics, University Medical Center Göttingen
  • Department of Medicine A, University Medicine Greifswald
  • Department of Medicine I, University Hospital of Halle
  • Ludwig-Maximilians - University of Munich
  • Medical Department II, Division of Gastroenterology, University Hospital of Leipzig
  • Technical University of Munich
  • University Medical Center Rostock

Registry information

Acronym: P-MAPS

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2021
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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