Pancreatitis - Microbiome as Predictor of Severity II

NCT06508502 | Recruiting DMC

• 1 other identifier: 2024-03261
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. The main questions it aims to answer are:

• Can the orointestinal microbiome robustly predict the course of acute pancreatitis?
• How does the microbiome impact the severity of an acute pancreatitis? Buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.

Conditions

Acute Pancreatitis; Acute Pancreatitis With Infected Necrosis

Keywords

Pancreatitis; Microbiome

Outcome Measures

Primary Outcomes (2)

• Novel microbiome species and/or functional metabolic pathways that are associated with the severity of acute pancreatitis

  To assess the microbial diversity and differential abundances of species within buccal and rectal swabs analyzed by ONT sequencing followed by prediction of metabolic pathways and metabolites using tools such as Megan6 and GapSeq stratified by the Revised Atlanta Classification and severity (necrotic collections that require intervention and/or organ failure \>48h), adjusted for multiple individual confounders.

  until discharge (up to 90 days)

• Classifier developed based on differentially regulated metabolites

  To assess the metabolite (predicted in 1. Primary endpoint) levels in stool and plasma samples by targeted metabolomics to develop a classifier based on differentially regulated metabolites to assess its discriminatory power in predicting Revised Atlanta Classification and severity.

  Until discharge (up to 90 days)

Secondary Outcomes (6)

• Mortality

  up to 1096 days (3 years)

• Length of hospital stay

  up to 90 days

• Post-discharge exocrine and endocrine insufficiency

  up to 90 days

• Post-discharge re-intervention

  up to 1096 days (3 years)

• Recurrent/chronic pancreatitis rate

  up to 1096 days (3 years)

Study Arms (3)

Revised Atlanta classifiaction (RAC) I - mild

No local or systemic complication

Revised Atlanta classifiaction (RAC) II - moderate severe

Local complications as necrosis or fluid collection or organ failure \< 48h

Revised Atlanta classifiaction (RAC) III - severe

Organ failure \> 48h

Eligibility Criteria

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

Study Population

Patients with acute pancreatitis within 48h after hospital admission. Acute pancreatitis is defined if 2 of the following criteria are fullfilled. 1. Lipase \> 3x the upper limit 2. Typical abdominal pain (belt-like upper abdominal pain) 3. Characteristic CT findings

You may qualify if:

• Patients with initial diagnosis (\< 48h) of acute pancreatitis
• Age ≥ 18 years
• Patients able to understand/ give their written consent

You may not qualify if:

• Recurrent acute pancreatitis (\>2 previous episodes)
• Clinical or imaging signs of chronic pancreatitis
• Referred patients with length of hospital stay \> 48h

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Goettingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Related Publications (7)

• Capurso G, Ponz de Leon Pisani R, Lauri G, Archibugi L, Hegyi P, Papachristou GI, Pandanaboyana S, Maisonneuve P, Arcidiacono PG, de-Madaria E. Clinical usefulness of scoring systems to predict severe acute pancreatitis: A systematic review and meta-analysis with pre and post-test probability assessment. United European Gastroenterol J. 2023 Nov;11(9):825-836. doi: 10.1002/ueg2.12464. Epub 2023 Sep 27.

  PMID: 37755341 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, Neesse A. Response to: short-chain fatty acids in patients with severe acute pancreatitis: friend or foe? Gut. 2024 Nov 11;73(12):e39. doi: 10.1136/gutjnl-2024-332236. No abstract available.

  PMID: 38453356 BACKGROUND

• van den Berg FF, Besselink MG, van Santvoort H. Short-chain fatty acids in patients with severe acute pancreatitis: friend or foe? Gut. 2024 Nov 11;73(12):e34. doi: 10.1136/gutjnl-2024-332129. No abstract available.

  PMID: 38360070 BACKGROUND

• Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Feb 23;371(9613):651-659. doi: 10.1016/S0140-6736(08)60207-X. Epub 2008 Feb 14.

  PMID: 18279948 BACKGROUND

• Beyer G, Hoffmeister A, Michl P, Gress TM, Huber W, Algul H, Neesse A, Meining A, Seufferlein TW, Rosendahl J, Kahl S, Keller J, Werner J, Friess H, Bufler P, Lohr MJ, Schneider A, Lynen Jansen P, Esposito I, Grenacher L, Mossner J, Lerch MM, Mayerle J; Collaborators:. S3-Leitlinie Pankreatitis - Leitlinie der Deutschen Gesellschaft fur Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) - September 2021 - AWMF Registernummer 021-003. Z Gastroenterol. 2022 Mar;60(3):419-521. doi: 10.1055/a-1735-3864. Epub 2022 Mar 9. No abstract available. German.

  PMID: 35263785 BACKGROUND

• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

  PMID: 23896955 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buccal and rectal swabs Stool Plasma All samples are stored at -80°C within 30 minutes after collection.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Christoph Ammer-Herrmenau, Dr

CONTACT

+491704075339; christoph.herrmenau@med.uni-goettingen.de

Jacob Hamm, Dr

CONTACT

+495513963231; jacob.hamm@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 18, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)