Gut barrier dysfunction post-ICU, leaky gut after ICU stay, intestinal dysbiosis Disturbance of the gut microbiome after an ICU stay, imbalance of gut microbiota after time in intensive care.
Conditions
Interventions
Participants in the intervention group will receive a once-daily oral supplementation of 30 × 10? pasteurized Akkermansia muciniphila bacteria in capsule form for a total duration of 56 days. Particip
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (=18 years) who have had sepsis during ICU admission, were treated in the ICU for at least 2 days, have received selective digestive decontamination (SDD) or cephalosporin, have been discharged to a regular ward, and are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Recent major gastrointestinal surgery, diagnosis of ulcerative colitis or Crohn’s disease, hematological malignancy and/or current use of immunomodulatory therapy, history of solid organ or stem cell transplantation, systemic corticosteroid use (=10 mg prednisone equivalent daily at ICU discharge), pregnancy, blood or plasma donation within 30 days prior to inclusion or planned donation during the intervention period, or any other condition that may pose a risk or interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined primary endpoint consists of: (1) safety, defined as the occurrence of adverse events during the 8-week intervention period, and (2) change in the abundance of butyrate-producing gut bacteria from baseline to day 56. These two components will be analyzed separately as well as jointly to evaluate the overall effect of PAM supplementation in ICU survivors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: (1) changes in gut microbiota composition, a- and ß-diversity, between study arms and compared to baseline, assessed at day 0, 28, and 56; (2) differences in functional immune and inflammatory response profiles between study arms at the same timepoints, assessed via blood-based cellular and cytokine analysis, including ex vivo stimulation assays of peripheral immune cells; (3) levels and longitudinal changes of markers of gut barrier function, such as circulating lipopolysaccharide-binding protein (LBP) and soluble CD14; (4) incidence of secondary infections and hospital readmissions within 12 months after treatment initiation; (5) change in insulin sensitivity. | — |
Countries
Netherlands
Contacts
Public ContactPDE Gaay Fortman
Amsterdam UMC
Outcome results
None listed