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Trial registered on ANZCTR
Registration number
ACTRN12608000004369
Ethics application status
Approved
Date submitted
21/12/2007
Date registered
7/01/2008
Date last updated
11/09/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Does the use of an enteral nutrition formula containing partially hydrolysed guar gum prevent diarrhoea in patients receiving enteral nutrition
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Scientific title
Does the use of an enteral nutrition formula containing partially hydrolysed guar gum prevent diarrhoea in patients receiving enteral nutrition
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diarrhoea
2655
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Condition category
Condition code
Diet and Nutrition
2773
2773
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0
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Other diet and nutrition disorders
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Diet and Nutrition
2782
2782
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Does the use of novacontrol, an enteral nutrition formula which contains 22g/L of dietary fibre (partially hydrolysed guar gum) prevent diarrhoea.
Participants will recieve sufficient enteral formula to meet thier individual nutrition requirements, the formula contains 22g/L of partially hydrolysed guar gum. Participants will recieve continuous enteral nutrition for 10 days via a nasogastric or PEG tube. If enteral nutrition is ceased prior to being in the study for 4 days the patients data will be disregarded and a new participant will be selected. There will be no follow up period beyond the 10 days.
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Intervention code [1]
2396
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Treatment: Drugs
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Intervention code [2]
2404
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Prevention
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Comparator / control treatment
Isosource HN - a standard enteral nutrition formula which contains no fibre. Enteral nutrition provided will be individual and based on meeting 100% of the patients nutrition requirements. Participants will recieve continuous enteral nutrition for 10 days via a nasogastric or PEG tube. If enteral nutrition is ceased prior to being in the study for 4 days the patients data will be disregarded and a new participant will be selected. There will be no follow up period beyond the 10 days.
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Control group
Active
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Outcomes
Primary outcome [1]
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Bowel motions (consistency and volume) will be recorded on the bristol stool chart and compared between groups
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Assessment method [1]
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Timepoint [1]
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Bowel actions will be recorded upon entry into the study and for up to 10 days during the study period. Total volume of bowel material per day will be calculated daily
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Secondary outcome [1]
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fluid balance chart to determine theraputic effect of fibre
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Assessment method [1]
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Timepoint [1]
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Daily from enrollement into trial for 10 days
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Eligibility
Key inclusion criteria
Adult inpatients of an acute hospital who are receiving enteral nutrition
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Gastrointestinal disease (crohns, ulcerative colitis, fistulas, newly formed stomas, infectious colitis, gastrointestinal surgery, short bowel) gastroparesis, pancreatitis, patients with encephalopathy recieving lactulose, patients who require elemental formula, patients with a spinal cord injury, drug overdose, Patients who have recieved total parenteral nutrition (TPN) in the previous 10 days, Pregnancy, Clostridium Difficule, oral diet, renal disease
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who are to recieve enteral nutrition will be invited to participate in the study and informed consent will be obtained. Subjects will be randomly allocated to groups by an associate researcher off site. All formula will contain a label stating formula a or formula b, only the researchers will be aware which is which. The unit dietitian providing direct patient care will be unaware
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised by stratified block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
522
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3084
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Maria Apostolides
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Address [1]
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Department of Nutrition and Dietetics
PO Box 5555 Heidelberg 3084 VIC
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
PO Box 5555
Heidelberg 3081
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Deakin University
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Address [1]
2629
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222 Burwood Hwy
Burwood
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Country [1]
2629
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Australia
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Other collaborator category [1]
114
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Individual
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Name [1]
114
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Kate Hamilton
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Address [1]
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PO Box 5555 Heidelberg 3084
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Country [1]
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Australia
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Other collaborator category [2]
115
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Commercial sector/Industry
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Name [2]
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Nestle Nutrition
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Address [2]
115
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327-333 Police rd
Mulgrave 3170
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Country [2]
115
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health Human Research Ethics Commitee
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Ethics committee address [1]
4852
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PO box 5555 Heidelberg 3084
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Ethics committee country [1]
4852
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Australia
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Date submitted for ethics approval [1]
4852
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05/12/2007
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Approval date [1]
4852
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Ethics approval number [1]
4852
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03135
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Summary
Brief summary
Feeding tube's areplaced into hopsital patient's gut so that liquid nutrition can be given when a patient is unable or unsafe to meet thier nutritional needs. A common side effect of receiving liquid nutrition through a feeding tube is diarrhoea. There are many causes of diarrhoea, such as infection, the use of certain medications or antibiotics. Long lasting diarrhoea may lead to dehydration and inadequate nutrition. This research project will test if a liquid formula containing a particular type of fibre given through a feeding tube can prevent diarrhoea. This new liquid formula is called Novacontrol Studies show that the use of a fibre (called partially hydrolysed guar gum) found in Novacontrol can prevent diarrhoea in some patients. We would like to test this at Austin Health. Currently there is no standard way to prevent diarrhoea in patients having liquid nutrition. To provide the best care for our patients at Austin Health, we would like to find a suitable way to prevent diarrhoea in patients receiving liquid nutrition. Results from our study may also help other people who are receiving liquid nutrition through a feeding tube in the future. Studies show that at least 20 grams of partially hydrolysed guar gum for every litre of liquid nutrition needs to be given to be beneficial in preventing diarrhoea in tube fed patients. Novacontrol contains this amount of fibre and is available for use in Australia. There are no studies which have examined the use of Novacontrol in preventing diarrhoea in tube fed patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
28259
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maria Apostolides
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Address
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Austin Health. Department of Nutrition and Dietetics. PO Box 5555 Heidelberg VIC 3084
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Country
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Australia
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Phone
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03 94965011
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Fax
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03 94963168
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Email
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maria.apostolides@austin.org.au
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Contact person for scientific queries
Name
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Tim Crowe
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Address
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Deakin University
222 Burwood Hwy
Burwood 3126
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Country
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Australia
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Phone
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94965000
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Fax
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Email
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tcrowe@deakin.edu.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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