Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256087
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2005-11-17
Brief Title:
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients
The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections
The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli
The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections
The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli
Detailed Description:
The patients are randomised to one of three treatment groups Each comprising of 100 patients
1 Standard therapy group Patients will receive enteral feeding with fibre aiming at the target feeding rate that is determined by the treating physician and the ICU dietician as is standard current practice Two capsule containing placebo will be given 12 hourly via the feeding tube
2 The first active treatment group will receive enteral feeding with fibre plus probiotic Lactobacillus fermentum included in the feeding regime Two capsules containing Lactobacillus fermentum 10 11 organisms per capsule will be delivered via the feeding tube 12 hourly
3 The second active treatment group will receive enteral feeding with fibre plus the probiotic Lactobacillus acidophilus included in the feeding regime Two capsules containing Lactobacillus acidophilus 2x10 9 organisms per capsule will be delivered via the feeding tube 12 hourly
1 Standard therapy group Patients will receive enteral feeding with fibre aiming at the target feeding rate that is determined by the treating physician and the ICU dietician as is standard current practice Two capsule containing placebo will be given 12 hourly via the feeding tube
2 The first active treatment group will receive enteral feeding with fibre plus probiotic Lactobacillus fermentum included in the feeding regime Two capsules containing Lactobacillus fermentum 10 11 organisms per capsule will be delivered via the feeding tube 12 hourly
3 The second active treatment group will receive enteral feeding with fibre plus the probiotic Lactobacillus acidophilus included in the feeding regime Two capsules containing Lactobacillus acidophilus 2x10 9 organisms per capsule will be delivered via the feeding tube 12 hourly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None