Acute PancreatitisP-MAPSNCT04777812
Pancreatitis - Microbiome As Predictor of Severity
A study testing Rectal and buccal swabs in people with Acute Pancreatitis, run by University Medical Center Goettingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Rectal and buccal swabs
- Type of treatment
- Pill or oral medicine
- How many people
- 424 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2020to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women Patients < 18 years; Patients who are incapable of giving consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Rectal and buccal swabs
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal and buccal swabsDiagnostic test
The oral and intestinal flora is collected from buccal and rectal swabs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Atlanta classification I-III
Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.
Measured: up to 8 weeks
Secondary outcomes (3)
Length of hospital stay
days in hospital during initial admission
Measured: up to 12 months
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
Measured: up to 12 months
Mortality
in hospital mortality during initial admission (%)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start17 Feb 2020
- Primary completion30 Sep 2023
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Rostock, Medical Department II, Division of Gastroenterology, University Hospital of Leipzig, LMU Klinikum, Department of Medicine I, University Hospital of Halle, Department of Medicine A, University Medicine Greifswald, Technical University of Munich, Department of Medical Bioinformatics, University Medical Center Göttingen, Department if Medical Statistics, University Medical Center Göttingen
- Responsible party
- Principal investigator, Albrecht Neesse, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777812
- Sponsor's protocol ID
- P-MAPS_02794
- Acronym
- P-MAPS
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32703080Ammer-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, Meier R, Antweiler KL, Asendorf T, Cameron S, Capurso G, Damm M, Dang L, Frost F, Hamm J, Hoffmeister A, Kocheva Y, Meinhardt C, Nawacki L, Nunes V, Panyko A, Ruiz-Rebollo ML, Florez-Pardo C, Phillip V, Pukitis A, Vaselane D, Rinja E, Sandru V, Schaefer A, Scholz R, Seelig J, Sirtl S, Ellenrieder V, Neesse A. Gut microbiota predict development of postdischarge diabetes mellitus in acute pancreatitis. Gut. 2026 Jan 8;75(2):316-325. doi: 10.1136/gutjnl-2025-336715.
PubMed 41298102Ammer-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.
PubMed 34332533
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatitis - Microbiome As Predictor of Severity
- ClinicalTrials.gov ID
- NCT04777812
- Acronym / sponsor ID
- P-MAPS / P-MAPS_02794
- Conditions
- Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Collaborators
- University Medical Center Rostock, Medical Department II, Division of Gastroenterology, University Hospital of Leipzig, LMU Klinikum, Department of Medicine I, University Hospital of Halle, Department of Medicine A, University Medicine Greifswald, Technical University of Munich, Department of Medical Bioinformatics, University Medical Center Göttingen, Department if Medical Statistics, University Medical Center Göttingen
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 2 Mar 2021 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women Patients < 18 years; Patients who are incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal and buccal swabsThe oral and intestinal flora is collected from buccal and rectal swabs. | Diagnostic test | – |
Primary outcome
Revised Atlanta classification I-III
Time frame: up to 8 weeks
Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.
3 secondary outcomes
Length of hospital stay
Time frame: up to 12 months
Numbers of interventions (surgical and endoscopical)
Time frame: up to 12 months
Mortality
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 32703080Ammer-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.
- Background: 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.
- Derived from this study: PubMed 41298102Ammer-Herrmenau C, Meier R, Antweiler KL, Asendorf T, Cameron S, Capurso G, Damm M, Dang L, Frost F, Hamm J, Hoffmeister A, Kocheva Y, Meinhardt C, Nawacki L, Nunes V, Panyko A, Ruiz-Rebollo ML, Florez-Pardo C, Phillip V, Pukitis A, Vaselane D, Rinja E, Sandru V, Schaefer A, Scholz R, Seelig J, Sirtl S, Ellenrieder V, Neesse A. Gut microbiota predict development of postdischarge diabetes mellitus in acute pancreatitis. Gut. 2026 Jan 8;75(2):316-325. doi: 10.1136/gutjnl-2025-336715.
- Derived from this study: PubMed 34332533Ammer-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal and buccal swabs in people with Acute Pancreatitis, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Atlanta classification I-III (time frame: up to 8 weeks). 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 NCT04777812, which also lists 4 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 30 Apr 2024.