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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
Scientific title
Does the use of an enteral nutrition formula containing partially hydrolysed guar gum prevent diarrhoea in patients receiving enteral nutrition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoea 2655 0
Condition category
Condition code
Diet and Nutrition 2773 2773 0 0
Other diet and nutrition disorders
Diet and Nutrition 2782 2782 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2396 0
Treatment: Drugs
Intervention code [2] 2404 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 3660 0
Bowel motions (consistency and volume) will be recorded on the bristol stool chart and compared between groups
Timepoint [1] 3660 0
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
Secondary outcome [1] 6184 0
fluid balance chart to determine theraputic effect of fibre
Timepoint [1] 6184 0
Daily from enrollement into trial for 10 days

Eligibility
Key inclusion criteria
Adult inpatients of an acute hospital who are receiving enteral nutrition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised by stratified block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 522 0
3084

Funding & Sponsors
Funding source category [1] 2912 0
Self funded/Unfunded
Name [1] 2912 0
Maria Apostolides
Country [1] 2912 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
PO Box 5555
Heidelberg 3081
Country
Australia
Secondary sponsor category [1] 2629 0
University
Name [1] 2629 0
Deakin University
Address [1] 2629 0
222 Burwood Hwy
Burwood
Country [1] 2629 0
Australia
Other collaborator category [1] 114 0
Individual
Name [1] 114 0
Kate Hamilton
Address [1] 114 0
PO Box 5555 Heidelberg 3084
Country [1] 114 0
Australia
Other collaborator category [2] 115 0
Commercial sector/Industry
Name [2] 115 0
Nestle Nutrition
Address [2] 115 0
327-333 Police rd
Mulgrave 3170
Country [2] 115 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4852 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 4852 0
Ethics committee country [1] 4852 0
Australia
Date submitted for ethics approval [1] 4852 0
05/12/2007
Approval date [1] 4852 0
Ethics approval number [1] 4852 0
03135

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28259 0
Address 28259 0
Country 28259 0
Phone 28259 0
Fax 28259 0
Email 28259 0
Contact person for public queries
Name 11416 0
Maria Apostolides
Address 11416 0
Austin Health. Department of Nutrition and Dietetics. PO Box 5555 Heidelberg VIC 3084
Country 11416 0
Australia
Phone 11416 0
03 94965011
Fax 11416 0
03 94963168
Email 11416 0
maria.apostolides@austin.org.au
Contact person for scientific queries
Name 2344 0
Tim Crowe
Address 2344 0
Deakin University
222 Burwood Hwy
Burwood 3126
Country 2344 0
Australia
Phone 2344 0
94965000
Fax 2344 0
Email 2344 0
tcrowe@deakin.edu.au

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.