RecruitingPhase 1ACTRN12605000167662

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.

Sponsor

Department of Health and Human Services (Tasmanian Government)

Enrollment

100 participants

Start Date

Aug 8, 2005

Study Type

Interventional

Conditions

Diarrhoeal illness and infection in critically ill patients

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether a probiotic supplement (containing beneficial bacteria, similar to what is found in yoghurt) can reduce diarrhoea in critically ill adults who are receiving nutrition through a feeding tube in an intensive care unit (ICU). Probiotics are thought to help restore healthy gut bacteria and may also lower the risk of infections. You may be eligible if: - You are 18 years of age or older - You are a patient admitted to the ICU and are expected to need tube feeding for at least 48 hours You may NOT be eligible if: - You are under 18 years old - You are expected to only need tube feeding for less than 48 hours - You have a known allergy to dairy/milk preparations - You have special dietary requirements that require intravenous nutrition (TPN) instead of tube feeding - You have a blockage or condition preventing tube feeding Talk to your doctor about whether this trial might be right for you.

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Interventions

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

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.

Locations(1)

Australia

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ACTRN12605000167662