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
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
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
THE AKKERMANSIA COMPANY
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator