None listed
Conditions
Interventions
Patients are randomised to one of three treatment groups, each comprising 100 patients:1. Standard therapy patients will receive enteral feeding (with fibre) aiming for the target rate determined by the treating clinician and the ICU dietician, as is current standard practice. Two capsules containing placebo will be given via the feeding tube twelve hourly as per active treatment group.2. The first active treatment group will receive enteral feeding (with fibre) plus probiotic Lactobacillus ferm
Patients are randomised to one of three treatment groups, each comprising 100 patients:1. Standard therapy patients will receive enteral feeding (with fibre) aiming for the target rate determined by the treating clinician and the ICU dietician, as is current standard practice. Two capsules containing placebo will be given via the feeding tube twelve hourly as per active treatment group.2. The first active treatment group will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentumincluded in the feeding regimen. 2 capsules containing Lactobacilli fermentum (1011 organisms per capsule) will be delivered via the feeding tube twelve hourly. 3. The second active treatment group will receive enteral feeding (with fibre) plus probiotic Lactobacillus acidophilus included in the feeding regimen. 2 capsules containing Lactobacilli acidophilus (2 x 109 organisms per capsule) will be delivered via the feeding tube twelve hourly.Enteral feeding volume will aim for the target rate determined by the treating clinician and the ICU dietician, as is current standard practice. Patients will receive study lactobacillus/placebo until enteral feeding is ceased or for a maximum time period of 14 days.
Sponsors
Intensive Care, Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Adult patient admitted to the ICU with an expected stay of more than 48 h.2.Patients who are to be commenced on enteral feeding via gastric or post-pyloric routes.3.Patients who consent or if the patient is incompetent, the next-of-kin who consent, to inclusion in the study.
Exclusion criteria
1.Patients aged less than 18 years.2.Patients who are already receiving probiotic treatment.3.The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20 mg/day, equivalent to 10% of the initial dose used to test for MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded.4.Patients with a known sensitivity to MSG will be excluded.5.Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As the Lactobacillus preparation contains live micro-organisms, immunosuppressed and pregnant patients will be excluded.6.Patients with a contra-indication to enteral feeding.7.Patients with a contra-indication to placement of an enteral feeding tube.8.Patients or next-of-kin who do not consent to inclusion in the study.9.Patients who are already enrolled in another study that may influence the outcome of the probiotic study.
Outcome results
None listed