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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: Rectal and buccal swabs

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • Recruiting
    • University Medical Centre Göttingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen
• Collaborators: Department of Medicine II, University Hospital Rostock; Medical Department II, Division of Gastroenterology, University Hospital of Leipzig; Department of Medicine II, University Hospital, LMU Munich; Department of Medicine I, University Hospital of Halle; Department of Medicine A, University Medicine Greifswald; Department of Medicine II, University Hospital rechts der Isar, Technical University Munich; Department of Medical Bioinformatics, University Medical Center Göttingen; Department if Medical Statistics, University Medical Center Göttingen

Publications and helpful links

General Publications

• Ammer-Herrmenau C, Pfisterer N, Weingarten MF, Neesse A. The microbiome in pancreatic diseases: Recent advances and future perspectives. United European Gastroenterol J. 2020 Oct;8(8):878-885. doi: 10.1177/2050640620944720. Epub 2020 Jul 23.
• Ammer-Herrmenau C, Asendorf T, Beyer G, Buchholz SM, Cameron S, Damm M, Frost F, Henker R, Jaster R, Phillip V, Placzek M, Ratei C, Sirtl S, van den Berg T, Weingarten MJ, Woitalla J, Mayerle J, Ellenrieder V, Neesse A. Study protocol P-MAPS: microbiome as predictor of severity in acute pancreatitis-a prospective multicentre translational study. BMC Gastroenterol. 2021 Jul 31;21(1):304. doi: 10.1186/s12876-021-01885-4.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: P-MAPS_02794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No