Acute PancreatitisP-MAPS IINCT06508502
Pancreatitis - Microbiome as Predictor of Severity II
An observational study of Acute Pancreatitis and Acute Pancreatitis With Infected Necrosis, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Acute Pancreatitis With Infected Necrosis
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with initial diagnosis (< 48h) of acute pancreatitis
- Age ≥ 18 years
- Patients able to understand/ give their written consent
Who cannot join
- Recurrent acute pancreatitis (>2 previous episodes)
- Clinical or imaging signs of chronic pancreatitis
- Referred patients with length of hospital stay > 48h
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Goettingen
Göttingen, Lower Saxony, 37075
Christoph Ammer-Herrmenau, Dr, +491704075339, christoph.herrmenau@med.uni-goettingen.de
About this study
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.
Read the detailed description
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.
- Keywords
- Pancreatitis, Microbiome
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until discharge (up to 90 days)
Secondary outcomes (6)
Mortality
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).
Measured: up to 1096 days (3 years)
Length of hospital stay
Association of length of hospital stay with microbial diversity and differential abundance and differentially regulated metabolites adjusted for multiple individual confounder.
Measured: up to 90 days
Post-discharge exocrine and endocrine insufficiency
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).
Measured: up to 90 days
Post-discharge re-intervention
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).
Measured: up to 1096 days (3 years)
Recurrent/chronic pancreatitis rate
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).
Measured: up to 1096 days (3 years)
Volatile organic compounds
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.
Measured: Until discharge (up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Ammer-Herrmenau, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508502
- Sponsor's protocol ID
- 2024-03261
- Acronym
- P-MAPS II
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37755341Ammer-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.
PubMed 38129103Ammer-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.
PubMed 38453356van 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.
PubMed 38360070Besselink 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.
PubMed 18279948Beyer 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.
PubMed 35263785Tenner 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.
PubMed 23896955
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatitis - Microbiome as Predictor of Severity II
- ClinicalTrials.gov ID
- NCT06508502
- Acronym / sponsor ID
- P-MAPS II / 2024-03261
- Keywords
- Pancreatitis, Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients with initial diagnosis (< 48h) of acute pancreatitis
- Age ≥ 18 years
- Patients able to understand/ give their written consent
Key exclusion criteria (3 listed)
- Recurrent acute pancreatitis (>2 previous episodes)
- Clinical or imaging signs of chronic pancreatitis
- Referred patients with length of hospital stay > 48h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
6 secondary outcomes
Mortality
Time frame: up to 1096 days (3 years)
Length of hospital stay
Time frame: up to 90 days
Post-discharge exocrine and endocrine insufficiency
Time frame: up to 90 days
Post-discharge re-intervention
Time frame: up to 1096 days (3 years)
Recurrent/chronic pancreatitis rate
Time frame: up to 1096 days (3 years)
Volatile organic compounds
Time frame: Until discharge (up to 90 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Results publication: PubMed 37755341Capurso 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.
- Results publication: PubMed 38129103Ammer-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.
- Results publication: PubMed 38453356Ammer-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.
- Results publication: PubMed 38360070van 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.
- Results publication: PubMed 18279948Besselink 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.
- Results publication: PubMed 35263785Beyer 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.
- Results publication: PubMed 23896955Tenner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Acute Pancreatitis With Infected Necrosis, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Ammer-Herrmenau, Dr (+491704075339, christoph.herrmenau@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508502, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.