Pancreatitis - Microbiome As Predictor of Severity

Acute Pancreatitis Clinical Trial

— P-MAPS  

Official title:

Pancreatitis - Microbiome As Predictor of Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777812
• Other study ID #: P-MAPS_02794
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: February 23, 2024

Study information

• Verified date: April 2024
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: February 23, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Centre Göttingen	Göttingen

Sponsors (9)

Lead Sponsor

Collaborator

University Medical Center Goettingen

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, Department of Medicine II, University Hospital rechts der Isar, Technical University Munich, Department of Medicine II, University Hospital Rostock, Department of Medicine II, University Hospital, LMU Munich, Medical Department II, Division of Gastroenterology, University Hospital of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revised Atlanta classification I-III	Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.	up to 8 weeks
Secondary	Length of hospital stay	days in hospital during initial admission	up to 12 months
Secondary	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
Secondary	Mortality	in hospital mortality during initial admission (%)	up to 12 months