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Trial registered on ANZCTR


Registration number
ACTRN12612000644864
Ethics application status
Approved
Date submitted
15/06/2012
Date registered
18/06/2012
Date last updated
18/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of diarrhoea in tube-fed patients by providing formula low in poorly absorbed sugars (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols or FODMAPs)
Scientific title
Management of diarrhoea in patients receiving enteral nutrition by reducing intake of poorly absorbed short-chain carbohydrates (FODMAPs)
Secondary ID [1] 280676 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enteral nutrition-associated diarrhoea 286701 0
Condition category
Condition code
Diet and Nutrition 286999 286999 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 287023 287023 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Providing patients receiving enteral nutrition with a standard enteral formula (that is in current use in Australia) of either lower or higher FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) content. The FODMAP content of the lower formula is 11.9g/L and the higher is 48.2g/L. The enteral nutrition regimen including required dose and mode of delivery will be prescribed by the unit dietitian. The study duration will be for up to seven days or the development of diarrhoea.
Intervention code [1] 285081 0
Treatment: Other
Intervention code [2] 285105 0
Prevention
Comparator / control treatment
Lower FODMAP enteral formula of 11.9g/L compared to higher FODMAP enteral formula of 48.2g/L. Both formulas are standard formulas in current use in Australia. The enteral nutrition regimen including required dose and mode of delivery will be prescribed by the unit dietitian. The study duration will be for up to seven days or the development of diarrhoea.
Control group
Active

Outcomes
Primary outcome [1] 287332 0
Proportion of patients developing diarrhoea as classifed by the validated King's Stool Chart.
Timepoint [1] 287332 0
Within a seven-day study duration.
Secondary outcome [1] 297922 0
Proportion of patients ceasing enteral nutrition due to poor tolerance as determined by the treating medical team, such as gastrointestinal complaints or high level gastric aspirates.
Timepoint [1] 297922 0
Within a seven-day study duration.
Secondary outcome [2] 297923 0
Number of bowel motions during the day from day four of study.
Timepoint [2] 297923 0
Day four to seven of study.
Secondary outcome [3] 297924 0
Proportion of patients with gastrointestinal adverse events, such as reported symptoms of nausea or reflux.
Timepoint [3] 297924 0
Within a seven-day study duration.
Secondary outcome [4] 297925 0
Proportion of patients that meet target volume as specified by their treating dietitian.
Timepoint [4] 297925 0
Within a seven-day study duration.
Secondary outcome [5] 297926 0
Proportion of patients with diarrhoea from Clostridium difficile which will be assessed on development of diarrhoea. On the development of diarrhoea, faeces will be collected for microscopy, culture and Clostridium difficile toxin assessment through hospital pathology.
Timepoint [5] 297926 0
If diarrhoea develops within the seven-day study duration.

Eligibility
Key inclusion criteria
Inpatients requiring enteral nutrition to provide at least 75% estimated nutritional requirements as determined by the assessing dietitian.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing diarrhoea
2. Enteral nutrition delivered directly into the jejunum
3. Patients with co-morbidities that predisposes them to diarrhoea, such as inflammatory bowel disease or previous intestinal resectional surgery
4. Patients anticipated to receive enteral nutrition in hospital for less than three days
5. Gastrointestinal surgery during current hospital admission
6. Patients admitted due to complication of gastrointestinal surgery
7. Patients requiring specialty enteral formula/regimen
8. Patients with psychiatric illness including anorexia nervosa

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)
Patients who are referred to the unit dietitian for commencement of enteral nutrition will be approached to participate in the trial. If enrolled, patient will receive an enteral nutrition regimen as prescribed by the unit dietitian, but randomised to one of two standard formulas; one of lower FODMAP content or one of higher FODMAP content. If the patient is unable to consent to study participation, the person responsible will be approached for consent.

The unit dietitian will know (and order) the identity of the formula. The study investigator who will collect data on faecal output will be blinded to the formula that is received. The formulas will be delivered to the ward, hung and administered in opaque bags by the foodservice staff to prevent the study investigator from identifying the formula. The formulas will be labelled and referred to in documentation as 'Formula A' or 'Formula B'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised by a computer-generate sequence. They will only receive one formula.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5403 0
3181
Recruitment postcode(s) [2] 5404 0
3128

Funding & Sponsors
Funding source category [1] 285445 0
Hospital
Name [1] 285445 0
The Alfred
Country [1] 285445 0
Australia
Funding source category [2] 285446 0
Hospital
Name [2] 285446 0
Box Hill Hospital
Country [2] 285446 0
Australia
Funding source category [3] 285447 0
University
Name [3] 285447 0
Monash University
Country [3] 285447 0
Australia
Primary sponsor type
University
Name
Monash University
Address
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 284295 0
None
Name [1] 284295 0
Address [1] 284295 0
Country [1] 284295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287459 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 287459 0
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 287459 0
Australia
Date submitted for ethics approval [1] 287459 0
23/02/2012
Approval date [1] 287459 0
23/04/2012
Ethics approval number [1] 287459 0
38/12
Ethics committee name [2] 287460 0
Eastern Health Research and Ethics Committee
Ethics committee address [2] 287460 0
5 Arnold St
Box Hill VIC 3128
Ethics committee country [2] 287460 0
Australia
Date submitted for ethics approval [2] 287460 0
21/07/2011
Approval date [2] 287460 0
10/05/2012
Ethics approval number [2] 287460 0
E07/1112

Summary
Brief summary
This study aims to provide patients receiving enteral nutrition with a lower or higher FODMAP formula and monitor the proportion of patients that develop diarrhoea. We hypothesise that the lower FODMAP formula will prevent the development of diarrhoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34313 0
Address 34313 0
Country 34313 0
Phone 34313 0
Fax 34313 0
Email 34313 0
Contact person for public queries
Name 17560 0
Emma Halmos
Address 17560 0
Block B, Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 17560 0
Australia
Phone 17560 0
+61399030233
Fax 17560 0
Email 17560 0
[email protected]
Contact person for scientific queries
Name 8488 0
Emma Halmos
Address 8488 0
Block B, Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 8488 0
Australia
Phone 8488 0
+61399030233
Fax 8488 0
Email 8488 0
[email protected]

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Results publications and other study-related documents

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