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NCT Number: NCT07295353

Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.

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

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Infections Inflammation Intensive Care Unit Survivors Microbiome Dysbiosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post Intensive Care Unit Syndrome Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pasteurized Akkermansia muciniphila

Dietary Supplement

Oral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care.

Placebo control

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Changes in gut microbiota composition

    Time frame: Day 0 (baseline), day 28, day 56

    Differences between arms and within-participant change from baseline in microbiota α-diversity and β-diversity

  2. Changes in circulating immune and inflammatory profiles

    Time frame: Day 0 (baseline), day 28, day 56

    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.

  3. Changes in gut barrier markers

    Time frame: Day 0 (baseline), day 28, day 56

    Plasma levels and changes from baseline of lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14); between-arm comparisons.

  4. Secondary infections and rehospitalizations

    Time frame: Through day 365

    Incidence of adjudicated secondary infections and all-cause rehospitalizations; comparison between PAM and placebo.

Other outcomes

  1. Host metabolic function

    Time frame: Day 0 (baseline), day 28, day 56

    Change from baseline in insulin sensitivity estimated by HOMA-%S, calculated from fasting plasma glucose and insulin; between-arm differences.

Study contacts

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

Duveke de Gaay Fortman, MD

CONTACT

[email protected]

+31205669111

Rebekka Bout

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • THE AKKERMANSIA COMPANY
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: PAM-ICU

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Dec 19, 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.

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