Table 1

Trial eligibility criteria

Inclusion criteria

  1. Adult patient within 48 hours of admission to an ICU

  2. Expected to require ICU-level care beyond the next calendar day

Exclusion criteria

  1. <18 years of age

  2. Absolute contraindication to receiving medication via the enteral route

  3. Known to be receiving probiotic therapy at the time of index hospitalisation

  4. Acute pancreatitis as a cause or complication of current admission

  5. Immunosuppression (defined as chemotherapy within the preceding 4 weeks or receiving ≥1.5 mg/kg methylprednisolone daily or equivalent)

  6. Neutropenia (neutrophil count ≤1×109/L)

  7. Prosthetic heart valve or permanent pacemaker

  8. Death is deemed to be inevitable as a result of the current acute illness AND either the treating clinician, the patient or the substitute decision-maker, are not committed to full active treatment

  9. Enrolment is not considered in the patient’s best interest

  10. Previously enrolled in ROCIT

  11. Unlikely to be residing near or visiting a study centre in 60 days

  12. Participating in a competing interventional study

  13. Pregnancy

  14. Admitted to hospital from a high-level nursing facility or rehabilitation facility

  • ICU, intensive care unit; ROCIT, Restoration Of gut microflora in Critical Illness Trial.