Trial registered on ANZCTR


Trial ID
ACTRN12605000167662
Ethics application status
Approved
Date submitted
3/08/2005
Date registered
17/08/2005
Date last updated
17/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoeal illness and infection in critically ill patients 262 0
Condition category
Condition code
Infection 294 294 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VSL#3 is a commercially available probiotic and helps to replenish the "good" bacteria in the small intestine, ensuring that the digestive system works efficiently and effectively. It is safe, easily digestible and freely available to all consumers and has demonstrated health benefits in clinical trials. Participants will be randomly assigned to a treatment or placebo group with in 48 hours of admission to the intensive care unit. Study participants will remain in the study for a maximum period of 21 days or until tube feeding is ceased by the patient's attending physician or the patient is discharged from hospital. At this point data collection would cease.
Study participants, intensive care nurses and attending physicians will be blinded to group membership. All critically ill patients who are unable to consume normal oral diet will be fed via a feeding tube utilising the ICU enteral feed algorithm.
The probiotic/placebo will be prepared in pharmacy and packaged in a 50 ml syringe and delivered to the intensive care unit (or ward) daily and matched with the participants study identification number. The VSL#3/VSL#3 placebo syringe will be administered to each study participant twice daily at 0900 hours and 2100 hours. The probiotic/placebo preparation will be administered by the intensive care nurse responsible for each patients care and delivered to the patient's digestive tract via either a nasogastric or nasojejunal feeding tube. Information relative to the record of stool output (time of episode, frequency of output, consistency and volume of stool output using the King's College Stool Chart will be entered on a 24 hour Data Collection Sheet. Permission has been sought and granted from the King's College Faculty of Dietetics [London] in reference to using the instrument for the purposes of this study. Information from the Daily Data Collection Sheet will be secured on a computer locked database in the intensive care unit.
Intervention code [1] 105 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 347 0
To compare the effect of the probiotic VSL #3 versus placebo administration of VSL#3 in intensive care patients receiving enteral feed.
Timepoint [1] 347 0
Secondary outcome [1] 786 0
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.
Timepoint [1] 786 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered envelopes which are not opened until a subject is enrolled. Envelopes are only opened in Pharmacy so that the appropriate treatment can be supplied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation function in Excel was used. No restrictions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 353 0
Hospital
Name [1] 353 0
Launceston General Hospital
Address [1] 353 0
Country [1] 353 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Human Services (Tasmanian Government)
Address
Country
Australia
Secondary sponsor category [1] 279 0
None
Name [1] 279 0
no secondary sponsor
Address [1] 279 0
Country [1] 279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1325 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 1325 0
Ethics committee country [1] 1325 0
Australia
Date submitted for ethics approval [1] 1325 0
Approval date [1] 1325 0
Ethics approval number [1] 1325 0
Ethics committee name [2] 1326 0
GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [2] 1326 0
Ethics committee country [2] 1326 0
Australia
Date submitted for ethics approval [2] 1326 0
Approval date [2] 1326 0
Ethics approval number [2] 1326 0

Summary
Brief summary
It is not clearly understood why some critically ill patients develop diarrhoea while being fed by stomach tube. Diarrhoeal illness has been linked to infection and treatment by antibiotics which can disrupt the normal functioning of the gastrointestinal tract. Excessive diarrhoea may cause patients not to digest the essential nutrients they need to overcome illness. Severe cases of diarrhoea may also lead to discomfort and loss of dignity for the patient. Health professionals continually seek new therapies to remedy the onset of diarrhoea and the potential discomforts associated with it.
The aim of this study is to find out whether commercially available probiotic preparations (like yoghurt type foods) have the ability to reduce the frequency of diarrhoea in patients receiving their nourishment by feed tube in the intensive care unit. A secondary aim of this study is to find out whether probiotic preparations can decrease infection rates in seriously ill patients. Probiotics are not drugs and through out the world they are considered to be very safe. They represent a range of food ingredients or supplements which can be bought from health food shops and supermarkets. These foods contain live microbes many of which normally reside in the intestines. Research suggests that these foods improve intestinal health by restoring the normal balance of microbes in the gastrointestinal tract.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36387 0
Address 36387 0
Country 36387 0
Phone 36387 0
Fax 36387 0
Email 36387 0
Contact person for public queries
Name 9294 0
Mr Terry Frohmader
Address 9294 0
1066 Lilydale Road
Underwood TAS 7268
Country 9294 0
Australia
Phone 9294 0
+61 3 63951277
Fax 9294 0
Email 9294 0
et_frohmader@bigpond.com.au
Contact person for scientific queries
Name 222 0
Dr John Gowardman
Address 222 0
Launceston General Hospital
Charles Street
Launceston TAS 7250
Country 222 0
Australia
Phone 222 0
+61 3 63487496
Fax 222 0
+61 3 63487495
Email 222 0
john.gowardman@dhhs.tas.gov.au