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Trial record 1 of 1 for:    NCT04777812
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Pancreatitis - Microbiome As Predictor of Severity (P-MAPS)

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ClinicalTrials.gov Identifier: NCT04777812
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : May 14, 2021
Sponsor:
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
Information provided by (Responsible Party):
Albrecht Neesse, 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Diagnostic Test: Rectal and buccal swabs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pancreatitis - Microbiome As Predictor of Severity
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis


Intervention Details:
  • Diagnostic Test: Rectal and buccal swabs
    The oral and intestinal flora is collected from buccal and rectal swabs.


Primary Outcome Measures :
  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 Outcome Measures :
  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 (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777812


Contacts
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Contact: Albrecht Neesse, MD, PhD 0049 551 39 ext 62313 albrecht.neesse@med.uni-goettingen.de

Locations
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Germany
University Medical Centre Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Volker Ellenrieder, MD    0049 551 39 ext 62313    volker.ellenrieder@med.uni-goettingen.de   
Sponsors and Collaborators
University Medical Center Goettingen
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albrecht Neesse, Prof. Dr. Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT04777812    
Other Study ID Numbers: P-MAPS_02794
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases