SepsisPAM-ICUNCT07295353
Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.
A study testing Pasteurized Akkermansia muciniphila in people with Sepsis and Post Intensive Care Unit Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
The goal of this clinical trial is to learn if daily oral supplementation with pasteurized Akkermansia muciniphila (PAM), an EFSA-approved food supplement, can support recovery in adults who have recently been treated in the ICU for sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Post Intensive Care Unit Syndrome, Critical Illness
- What is being tested?
- Pasteurized Akkermansia muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- Treated in the ICU for at least 2 days and discharged to a regular clinical ward
- Diagnosed with sepsis during ICU admission
- Received selective digestive decontamination (SDD) or cephalosporin
- Capable of giving written informed consent
Who cannot join
- Recent major gastrointestinal surgery
- Diagnosed with ulcerative colitis or Crohn's disease
- Presence of a hematological malignancy and/or current use of immunomodulatory therapy (e.g., CAR-T cell therapy or immune checkpoint inhibitors) Use of systemic immunomodulatory drugs or corticosteroids (defined as ≥10 mg prednisone equivalent daily at ICU discharge), at the time of inclusion.
- History of solid organ or stem cell transplantation
- Pregnancy or lactation
- Donation of blood or plasma within 30 days prior to inclusion or planned donation during the intervention period
- Any other condition that, in the opinion of the investigator, could pose a risk to the subject or interfere with study result
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if daily oral supplementation with pasteurized Akkermansia muciniphila (PAM), an EFSA-approved food supplement, can support recovery in adults who have recently been treated in the ICU for sepsis.
The main questions it aims to answer are:
Read more
- Is PAM safe to take for 56 days after ICU discharge?
- Does PAM increase the abundance of beneficial butyrate-producing bacteria in the gut?
Researchers will compare PAM to a placebo (a capsule that looks the same but has no active ingredient) to see if PAM improves gut microbiota and immune recovery.
Participants will:
- Take PAM or placebo capsules once daily for 56 days
- Provide stool and blood samples at baseline, day 28, and day 56
- Receive a follow-up phone call about their health 1 year after starting the study
- Conditions
- Sepsis, Post Intensive Care Unit Syndrome, Critical Illness, Microbiome Dysbiosis, Intensive Care Unit Survivors
- Being tested
- Pasteurized Akkermansia muciniphila, Placebo Control
- Keywords
- Pasteurized Akkermansia muciniphila, Akkermansia muciniphila, Postbioticum, Microbiome, PAM, Gut Barrier Function, Post-Sepsis Recovery, Randomized Controlled Trial
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized Akkermansia muciniphilaDietary supplement
Oral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care.
Placebo ControlOther
Oral administration of placebo capsules matched in appearance and dosing schedule to the PAM capsules, once daily for 56 days, in addition to standard care. The placebo contains no active component.
| Study group | Role | What they receive |
|---|---|---|
| Pasteurized Akkermansia muciniphila (PAM) | Experimental | Oral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care. Receives: Dietary Supplement: Pasteurized Akkermansia muciniphila |
| Placebo | Placebo comparator | Oral administration of placebo capsules matched in appearance and dosing schedule to the PAM capsules, once daily for 56 days, in addition to standard care. The placebo contains no active component. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abundance of butyrate-producing bacteria
Difference (Δ) from baseline in the relative abundance of gut butyrate-producing bacteria at day 56, assessed by shotgun metagenomic sequencing (taxa/functional pathways associated with butyrate production), comparing PAM vs placebo at the end of the intervention
Measured: Baseline and day 56
Safety (occurrence of adverse events)
Proportion of participants with ≥1 adverse event (AE) and total AE count, summarized by severity and relatedness, comparing PAM vs placebo at end of intervention
Measured: Baseline to day 56 (end of intervention)
Secondary outcomes (4)
Changes in gut microbiota composition
Differences between arms and within-participant change from baseline in microbiota α-diversity and β-diversity
Measured: Day 0 (baseline), day 28, day 56
Changes in circulating immune and inflammatory profiles
Between-arm differences and longitudinal changes in systemic immune profiles, including major innate and adaptive subsets and activation markers. In addition, ex vivo whole blood stimulations will be performed to quantify cytokine production in response to microbial ligands.
Measured: Day 0 (baseline), day 28, day 56
Changes in gut barrier markers
Plasma levels and changes from baseline of lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14); between-arm comparisons.
Measured: Day 0 (baseline), day 28, day 56
Secondary infections and rehospitalizations
Incidence of adjudicated secondary infections and all-cause rehospitalizations; comparison between PAM and placebo.
Measured: Through day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a parallel-group design to receive either pasteurized Akkermansia muciniphila supplementation or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- THE AKKERMANSIA COMPANY, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, W. J. Wiersinga, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- JW Wiersinga, Professor, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295353
- Sponsor's protocol ID
- NL-009844
- Acronym
- PAM-ICU
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.
- ClinicalTrials.gov ID
- NCT07295353
- Acronym / sponsor ID
- PAM-ICU / NL-009844
- Conditions
- Sepsis, Post Intensive Care Unit Syndrome, Critical Illness, Microbiome Dysbiosis, Intensive Care Unit Survivors
- Keywords
- Pasteurized Akkermansia muciniphila, Akkermansia muciniphila, Postbioticum, Microbiome, PAM, Gut Barrier Function, Post-Sepsis Recovery, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- THE AKKERMANSIA COMPANY, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Dec 2025 (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 clinical trial is to learn if daily oral supplementation with pasteurized Akkermansia muciniphila (PAM), an EFSA-approved food supplement, can support recovery in adults who have recently been treated in the ICU for sepsis.
The main questions it aims to answer are:
- Is PAM safe to take for 56 days after ICU discharge?
- Does PAM increase the abundance of beneficial butyrate-producing bacteria in the gut?
Researchers will compare PAM to a placebo (a capsule that looks the same but has no active ingredient) to see if PAM improves gut microbiota and immune recovery.
Participants will:
- Take PAM or placebo capsules once daily for 56 days
- Provide stool and blood samples at baseline, day 28, and day 56
- Receive a follow-up phone call about their health 1 year after starting the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a parallel-group design to receive either pasteurized Akkermansia muciniphila supplementation or placebo.
| Arm | Type | Receives |
|---|---|---|
| Pasteurized Akkermansia muciniphila (PAM) | Experimental | Dietary Supplement: Pasteurized Akkermansia muciniphilaOral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care. |
| Placebo | Placebo comparator | Other: Placebo ControlOral administration of placebo capsules matched in appearance and dosing schedule to the PAM capsules, once daily for 56 days, in addition to standard care. The placebo contains no active component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Treated in the ICU for at least 2 days and discharged to a regular clinical ward
- Diagnosed with sepsis during ICU admission
- Received selective digestive decontamination (SDD) or cephalosporin
- Capable of giving written informed consent
Key exclusion criteria (7 listed)
- Recent major gastrointestinal surgery
- Diagnosed with ulcerative colitis or Crohn's disease
- Presence of a hematological malignancy and/or current use of immunomodulatory therapy (e.g., CAR-T cell therapy or immune checkpoint inhibitors) Use of systemic immunomodulatory drugs or corticosteroids (defined as ≥10 mg prednisone equivalent daily at ICU discharge), at the time of inclusion.
- History of solid organ or stem cell transplantation
- Pregnancy or lactation
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 |
|---|---|---|
| Pasteurized Akkermansia muciniphilaOral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care. | Dietary supplement | Pasteurized Akkermansia muciniphila (PAM) |
| Placebo ControlOral administration of placebo capsules matched in appearance and dosing schedule to the PAM capsules, once daily for 56 days, in addition to standard care. The placebo contains no active component. | Other | Placebo |
Primary outcome
Change in abundance of butyrate-producing bacteria
Time frame: Baseline and day 56
Difference (Δ) from baseline in the relative abundance of gut butyrate-producing bacteria at day 56, assessed by shotgun metagenomic sequencing (taxa/functional pathways associated with butyrate production), comparing PAM vs placebo at the end of the intervention
Safety (occurrence of adverse events)
Time frame: Baseline to day 56 (end of intervention)
Proportion of participants with ≥1 adverse event (AE) and total AE count, summarized by severity and relatedness, comparing PAM vs placebo at end of intervention
4 secondary outcomes
Changes in gut microbiota composition
Time frame: Day 0 (baseline), day 28, day 56
Changes in circulating immune and inflammatory profiles
Time frame: Day 0 (baseline), day 28, day 56
Changes in gut barrier markers
Time frame: Day 0 (baseline), day 28, day 56
Secondary infections and rehospitalizations
Time frame: Through day 365
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 19 Dec 2025.
- 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.
JW Wiersinga, Professor principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized Akkermansia muciniphila in people with Sepsis and Post Intensive Care Unit Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Duveke de Gaay Fortman, MD (+31205669111, p.d.e.degaayfortman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abundance of butyrate-producing bacteria (time frame: Baseline and day 56). 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?
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 19 Dec 2025.