A double blind randomised placebo-controlled intervention trial to determine the efficacy of the probiotic VSL #3 in reducing the incidence and or frequency of diarrhoea in enterally-fed critically ill patients.
Phase 1
Recruiting
- Conditions
- Diarrhoeal illness and infection in critically ill patientsInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12605000167662
- Lead Sponsor
- Department of Health and Human Services (Tasmanian Government)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
All prospective adult participants that may require tube feeding as part of their routine management of their illness while a patient admitted to the ICU will be screened preoperatively in the pre-admission clinic or on admission to the ICU.
Exclusion Criteria
Patients with the following characteristics would be excluded from the study; < 18 years Likely to be tube fed < 48 hours Allergy to milk preparations Present with special dietary requirements (other than diabetic or renal considerations) requiring Total Parenteral Nutrition (TPN) Present with any condition that might interfere with the delivery of enteral feeds such as obstruction of the gastrointestinal tract.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of the probiotic VSL #3 versus placebo administration of VSL#3 in intensive care patients receiving enteral feed.[]
- Secondary Outcome Measures
Name Time Method To evaluate the effect of VSL #3 versus placebo administration of VSL #3 on the markers of infection of critically ill patients receiving enteral feeding. Data collection relevant to bacteriological markers of infection include routine testing of Central Access Devices tip assays, blood, tracheal aspirates and urine cultures. Data collection relevant to the biochemical markers of inflammation include the routine testing of immunoglobulins (IgG, IgM and IgA), 'C' Reactive Protein and Interleukin 6 and 10 assays.[]