Clinical trial NCT04777812: Pancreatitis - Microbiome As Predictor of Severity
Official title: Pancreatitis - Microbiome As Predictor of Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
Collaborators: name: Department of Medicine II, University Hospital Rostock
name: Medical Department II, Division of Gastroenterology, University Hospital of Leipzig
name: Department of Medicine II, University Hospital, LMU Munich
name: Department of Medicine I, University Hospital of Halle
name: Department of Medicine A, University Medicine Greifswald
name: Department of Medicine II, University Hospital rechts der Isar, Technical University Munich
name: Department of Medical Bioinformatics, University Medical Center Göttingen
name: Department if Medical Statistics, University Medical Center Göttingen
First posted: 2021-03-02
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Revised Atlanta classification I-III
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 12 months
measure: Numbers of interventions (surgical and endoscopical)
timeFrame: up to 12 months
measure: Mortality
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Centre Göttingen
Study officials:
References:
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.
citation: 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.
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.