Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06508502

Pancreatitis - Microbiome as Predictor of Severity II

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Pancreatitis Acute Pancreatitis With Infected Necrosis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, Lower Saxony, 37075, Germany

Location status: Recruiting

Location contact

Christoph Ammer-Herrmenau, Dr

CONTACT

[email protected]

+491704075339

About this study

Despite intensive research, early prediction of the course of acute pancreatitis (AP) is still not satisfactorily possible. Results of a European multicenter study showed that the intestinal microbiome is superior to established scores as a marker of severity in patients with AP. Hereby, a classifier was established using 16 differentially abundant rectal species and systemic inflammatory response syndrome (SIRS) and achieved an AUROC of 85%. Surprisingly, all species in the severe AP group were members of taxonomic families known for their short-chain fatty acid (SFCA) production. This observation contrasts with translational pancreatitis studies in mice. Based on these publications, a clinical trial is currently being initiated to treat severe AP with SCFA (NCT06147635). However, previous well-designed RCT that analyzed the effects of probiotics in predicted severe AP resulted in a worse outcome for patients in the probiotic arm. Consequently, national and international guidelines recommend against the usage of probiotics in AP.

Collectively, more research is needed to further elucidate the role of the oro-intestinal microbiota in the development of severe AP. To validate the results of previously mentioned multicenter study and to profoundly analyze the role of microbial metabolites and the fungeome, patients with AP will be prospectively recruited.

  • Buccal and rectal swabs, stool and plasma will be obtained to analyze the orointestinal microbiome and microbial derived metabolites.
  • Centers from different continents with different ethical background and dietary habits will enroll patients to gain a more generalizable microbial profile.
  • Microbial shifts were observed between severe AP (RAC 3) and mild/ moderate severe (RAC 1+2).
  • It is expected that the microbial compositions change during the inflammatory process upon early phase of pancreatitis. To minimize this microbial alternating effect a short time frame from hospital admission to recruitment (48h) is set.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: until discharge (up to 90 days)

    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.

  2. Classifier developed based on differentially regulated metabolites

    Time frame: Until discharge (up to 90 days)

    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.

Secondary outcomes

  1. Mortality

    Time frame: up to 1096 days (3 years)

    Association of mortality with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).

  2. Length of hospital stay

    Time frame: up to 90 days

    Association of length of hospital stay with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder.

  3. Post-discharge exocrine and endocrine insufficiency

    Time frame: up to 90 days

    Association of post-discharge exocrine and endocrine insufficiency with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).

  4. Post-discharge re-intervention

    Time frame: up to 1096 days (3 years)

    Association of post-discharge re-intervention with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).

  5. Recurrent/chronic pancreatitis rate

    Time frame: up to 1096 days (3 years)

    Association of recurrent/chronic pancreatitis rate with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder. Long-term outcomes will be assessed in the current cohort (P-MAPS II), as well as in the previously established P-MAPS I cohort (NCT04777812).

  6. Volatile organic compounds

    Time frame: Until discharge (up to 90 days)

    Assessment of volatile organic compounds (VOCs) in a subset of the study cohort (n = 60), including group comparisons based on the revised Atlanta classification and severity, as well as correlation of VOC concentrations with corresponding plasma levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Ammer-Herrmenau, Dr

CONTACT

[email protected]

+491704075339

Jacob Hamm, Dr

CONTACT

[email protected]

+495513963231

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Acronym: P-MAPS II

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.