NCT07295353
Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.
Not Yet Recruiting · Not Applicable · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · registry updated 2025-12-19
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
Inclusion
- 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
- 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