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

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rectal and buccal swabs
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Pancreatitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Centre GöttingenRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of hospital stay
days in hospital during initial admission
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
Mortality
in hospital mortality during initial admission (%)

Full Information

First Posted
February 25, 2021
Last Updated
May 13, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT04777812
Brief Title
Pancreatitis - Microbiome As Predictor of Severity
Acronym
P-MAPS
Official Title
Pancreatitis - Microbiome As Predictor of Severity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Rectal and buccal swabs
Intervention Description
The oral and intestinal flora is collected from buccal and rectal swabs.
Primary Outcome Measure Information:
Title
Revised Atlanta classification I-III
Description
Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
days in hospital during initial admission
Time Frame
up to 12 months
Title
Numbers of interventions (surgical and endoscopical)
Description
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
Time Frame
up to 12 months
Title
Mortality
Description
in hospital mortality during initial admission (%)
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albrecht Neesse, MD, PhD
Phone
0049 551 39
Ext
62313
Email
albrecht.neesse@med.uni-goettingen.de
Facility Information:
Facility Name
University Medical Centre Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Ellenrieder, MD
Phone
0049 551 39
Ext
62313
Email
volker.ellenrieder@med.uni-goettingen.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32703080
Citation
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.
Results Reference
background
PubMed Identifier
34332533
Citation
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.
Results Reference
derived

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Pancreatitis - Microbiome As Predictor of Severity

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