RecruitingACTRN12605000543684

The effect of prophylactic probiotic lactobacilli in enteral feeding on nosocomiial pneumonia rates in critically ill patients.

Sponsor

Intensive Care, Royal Melbourne Hospital

Enrollment

300 participants

Start Date

Aug 18, 2004

Study Type

Interventional

Conditions

Nosocomial pneumonia rates in critically ill patients.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding probiotic bacteria (specifically Lactobacillus acidophilus) to tube feeding (enteral nutrition) for critically ill patients in intensive care can help prevent pneumonia that develops in hospital settings. Hospital-acquired pneumonia is a serious complication that can be life-threatening in ICU patients. Probiotics are live beneficial bacteria that may help protect the gut and immune system. You may be eligible if: - You are 18 years or older - You are admitted to the ICU and expected to stay for more than 48 hours - You are receiving or about to start tube feeding through the stomach or small bowel - You or your next-of-kin have given consent to participate You may NOT be eligible if: - You are already receiving probiotic treatment - You have asthma or recurring hives (as the preparation contains a small amount of MSG) - You have a known sensitivity to MSG - You have HIV infection, are taking immunosuppressant drugs, or are pregnant - You have a condition that prevents tube feeding - You are already enrolled in another study that might affect the results Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(1)

Australia

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ACTRN12605000543684