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
Parallel
Pasteurized Akkermansia muciniphila
Dietary supplementOral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care.
Placebo Control
Other interventionOral 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.
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
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
Changes in gut microbiota composition
Differences between arms and within-participant change from baseline in microbiota α-diversity and β-diversity
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.
Changes in gut barrier markers
Plasma levels and changes from baseline of lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14); between-arm comparisons.
Secondary infections and rehospitalizations
Incidence of adjudicated secondary infections and all-cause rehospitalizations; comparison between PAM and placebo.
Host metabolic function
Change from baseline in insulin sensitivity estimated by HOMA-%S, calculated from fasting plasma glucose and insulin; between-arm differences.
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
THE AKKERMANSIA COMPANY
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
