Pancreatitis - Microbiome As Predictor of Severity

NCT04777812 | Completed

• 1 other identifier: P-MAPS_02794
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Revised Atlanta classification I-III

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

  up to 8 weeks

Secondary Outcomes (3)

• Length of hospital stay

  up to 12 months

• Numbers of interventions (surgical and endoscopical)

  up to 12 months

• Mortality

  up to 12 months

Interventions

Rectal and buccal swabs DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women Patients \< 18 years; Patients who are incapable of giving consent

Sponsors & Collaborators

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

Study Sites (1)

University Medical Centre Göttingen

Göttingen, 37075, Germany

Location

Related Publications (4)

• 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.

  PMID: 32703080 BACKGROUND

• Ammer-Herrmenau C, Antweiler KL, Asendorf T, Beyer G, Buchholz SM, Cameron S, Capurso G, Damm M, Dang L, Frost F, Gomes A, Hamm J, Henker R, Hoffmeister A, Meinhardt C, Nawacki L, Nunes V, Panyko A, Pardo C, Phillip V, Pukitis A, Rasch S, Riekstina D, Rinja E, Ruiz-Rebollo ML, Sirtl S, Weingarten M, Sandru V, Woitalla J, Ellenrieder V, Neesse A. Gut microbiota predicts severity and reveals novel metabolic signatures in acute pancreatitis. Gut. 2024 Feb 23;73(3):485-495. doi: 10.1136/gutjnl-2023-330987.

  PMID: 38129103 BACKGROUND

• Ammer-Herrmenau C, Meier R, Antweiler KL, Asendorf T, Cameron S, Capurso G, Damm M, Dang L, Frost F, Hamm J, Hoffmeister A, Kocheva Y, Meinhardt C, Nawacki L, Nunes V, Panyko A, Ruiz-Rebollo ML, Florez-Pardo C, Phillip V, Pukitis A, Vaselane D, Rinja E, Sandru V, Schaefer A, Scholz R, Seelig J, Sirtl S, Ellenrieder V, Neesse A. Gut microbiota predict development of postdischarge diabetes mellitus in acute pancreatitis. Gut. 2026 Jan 8;75(2):316-325. doi: 10.1136/gutjnl-2025-336715.

  PMID: 41298102 DERIVED

• 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.

  PMID: 34332533 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: February 17, 2020
• Primary Completion: September 30, 2023
• Study Completion: February 23, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)