None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether probiotic therapy in critically ill patients admitted to an ICU reduces hospital-acquired infection, and hence reduces risk of death and time in hospital.
Interventions
Intervention
Participants randomised to probiotics will receive a once daily administration of a single capsule of probiotic therapy containing 20 billion colony forming units of Lactobacillus plantarum strain 299v. Participants receiving oral antibiotics will not receive administration of the study drug within two hours of a dose of oral antibiotics. In vitro testing of the product has been completed locally confirming viable bacteria at a colony count within 0.1 log10 of the expected value.
Intervention Participants randomised to probiotics will receive a once daily administration of a single capsule of probiotic therapy containing 20 billion colony forming units of Lactobacillus plantarum strain 299v. Participants receiving oral antibiotics will not receive administration of the study drug within two hours of a dose of oral antibiotics. In vitro testing of the product has been completed locally confirming viable bacteria at a colony count within 0.1 log10 of the expected value. Participants will be discouraged from initiating any additional probiotic therapy after discharge from index hospitalisation until study completion (day-60). All other treatment will remain at the discretion of the treating team. Minimisation of contamination by development of an SOP for the handling and administration of probiotics based on published standard. Participants will be provided a study drug diary to record adherence and requested to return study drug bottles at the end of the study period for pill counts and reconciliation.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to the ICU or high dependency area for less than 48 hours * Anticipated to require intensive care or high dependency area care beyond the next calendar day
Exclusion criteria
1. less than 18 years of age 2. Absolute contraindication to receiving medication via the enteral route 3. Known to be receiving probiotic therapy at time of index hospitalisation 4. Acute pancreatitis as a cause or complication of current admission 5. Immunosuppressed, e.g. chemotherapy within four weeks of admission, receiving greater than or equal to 1.5mg/kg methylprednisolone daily or equivalent for more than four days 6. Neutropenia (neutrophil count less than 1x109/L) 7. Prosthetic heart valve or permanent pace maker 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 not considered in the patient’s best interest 10. Previously enrolled in the ROCIT study 11. Unlikely to be residing in the Perth Metropolitan area in 60 days time 12. Participating in a competing interventional study 13. Pregnancy 14. Admitted to hospital from a high level nursing facility or rehabilitation facility
Outcome results
None listed