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Not yet recruiting NCT07295353

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

No phase Interventional Sepsis Post Intensive Care Unit Syndrome Critical Illness Microbiome Dysbiosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pasteurized Akkermansia muciniphila, Placebo Control.
Who it may be relevant to
Registry conditions: Sepsis, Post Intensive Care Unit Syndrome, Critical Illness, Microbiome Dysbiosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Dietary supplement Pasteurized Akkermansia muciniphila
    Oral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care.
  • Other Placebo Control
    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 outcome measures

  • Change in abundance of butyrate-producing bacteria [Time frame: Baseline and day 56]
  • Safety (occurrence of adverse events) [Time frame: Baseline to day 56 (end of intervention)]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07295353 · NL-009844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗