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Trial registered on ANZCTR
Registration number
ACTRN12613000500752
Ethics application status
Approved
Date submitted
22/04/2013
Date registered
7/05/2013
Date last updated
7/05/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pilot study assessing the effects of poorly absorbed sugars in enteral formula on colonic gas production and symptom induction in healthy subjects
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Scientific title
Pilot study assessing the effects of poorly absorbed sugars in enteral formula on colonic gas production in healthy subjects
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Secondary ID [1]
282375
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Nil
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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:
Enteral nutrition-associated diarrhoea
288957
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Condition category
Condition code
Oral and Gastrointestinal
289291
289291
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Diet and Nutrition
289407
289407
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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
Participants will ingest (orally) one dose of the following fasted (on waking) before a minimum of two-day washout period before crossing over to all other arms:
Arm 1 - 15g lactulose made up to 100mL solution
Arm 2 - 500mL of enteral formula Isosource'Registered Trademark' HN
Arm 3 - 500mL of enteral formula Isosource'Registered Trademark' 1.5
Arm 1 will be ingested first in all participants, then Arm 2 and Arm 3 will be allocated in random order determined by a computer-generated sequence. Someone who is not a study investigator will label the two enteral formulas as 'Blue formula' and 'Red formula' so that both the study investigators and participants are blinded to the formulas.
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Intervention code [1]
287008
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Treatment: Other
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Comparator / control treatment
Arm 1 - Active control: 15g lactulose made up to 100mL solution ingested orally in one dose on waking.
Lactulose is an osmotic laxative or a sugar that is unabsorbed in the small intestine, thereby reaching the large intestine. Here it will be fermented by bacteria and produce gases including hydrogen (which can be measured on breath) and possible gut symptoms such as diarrhoea.
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Control group
Active
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Outcomes
Primary outcome [1]
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Breath hydrogen after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
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Assessment method [1]
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Timepoint [1]
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12 hours after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
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Secondary outcome [1]
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Breath methane after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
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Assessment method [1]
302400
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Timepoint [1]
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12 hours after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
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Secondary outcome [2]
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Severity of overall gut symptoms and specific symptoms of bloating, pain and satisfaction with stool consistency rated by a 100 mm visual analogue scale following ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
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Assessment method [2]
302401
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Timepoint [2]
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The day after ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
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Secondary outcome [3]
302402
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Consistency of bowel motions rated by the Bristol Stool Chart following ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
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Assessment method [3]
302402
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Timepoint [3]
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The day following ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
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Eligibility
Key inclusion criteria
Healthy subjects or subjects with functional gut symptoms such as irritable bowel syndrome over the age of 18 years
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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?
Yes
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Key exclusion criteria
1. Organic disease or condition predisposing the patient to diarrhoea (e.g. inflammatory bowel disease, bowel resection, untreated coeliac disease)
2. Non-breath hydrogen producer after lactulose ingestion
3. Use of antidiarrhoeal medications for one week prior to study commencement
4. Probiotic or prebiotic use for two weeks prior to study commencement
5. Antibiotic use for two weeks prior to study commencement
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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)
Healthy subjects and subjects with functional gut symptoms will be recruited through word of mouth. Potential subjects will have the study described to them by a study investigator and by the trial explanatory statement. If the potential subjects are happy to participate, they will sign the consent form and be randomised to receive one of the trial enteral formulas before crossing over to the other trial enteral formula. Randomisation will occur via computer-generated randomisation which will allocate each subject to their first formula ingestion. This will be conducted by a study investigator, however the formulas will be coded as 'Blue formula' and 'Red formula'. Both the study investigator and subjects will be blinded to formula identification.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software to identify which formula the subject will receive first.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The statistical tests performed for the comparison between the three treatment arms include: one-way repeated measures ANOVA for continuous variables and the Chi-squared test will be used for categorical variables. Area under the curve for breath hydrogen and methane will also be assessed.
Sample size to estimate a difference in the primary endpoint of breath hydrogen cannot be determined as there are no known studies comparing breath hydrogen after ingestion of one bolus of varying FODMAPs doses. The formulation of Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN which were previously investigated has recently been changed, therefore accessibility of the original formulations within a reasonable expiry date for use in this study is limited. We currently possess enough Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN to supply a maximum of 34 participants. This will be the study sample size.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/04/2013
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Actual
3/04/2013
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Date of last participant enrolment
Anticipated
21/04/2013
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Actual
17/04/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
34
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Department of Gastroenterology, Central Clinical School, Monash University
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Address [1]
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Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
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Country [1]
287148
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Australia
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Primary sponsor type
University
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Name
Department of Gastroenterology, Central Clinical School, Monash University
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Address
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
285915
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Country [1]
285915
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289146
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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Clayton Campus
Wellington Rd
Clayton VIC 3800
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/01/2013
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Approval date [1]
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03/04/2013
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Ethics approval number [1]
289146
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CF13/269 - 2013000108
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Summary
Brief summary
Diarrhoea amongst hospitalised patients receiving enteral formula (tube-feeding) is common. Previous research has suggested that one possible reason for this is the high content of poorly absorbed sugars called FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) in the formula. FODMAPs enter the large intestine where they get fermented by bacteria, produce gas and draw water in to the large intestine. In large enough doses, this may contribute to diarrhoea. We hypothesise that giving a formula we believe is high FODMAP compared to a formula we believe is low FODMAP will produce different amounts of large intestinal gas. This can be measure by collecting the breath after drinking these formulas and measuring the levels of gas in the breath. We will then compare this to a the FODMAP lactulose, which is a sugar that is known to produce gas in everyone. This will show us if there are FODMAPs in the formulas and a rough estimation of quantity.
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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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Prof Peter Gibson
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Address
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Head of Gastroenterology
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0189
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Fax
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Email
39466
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[email protected]
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Contact person for public queries
Name
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Ms Emma Halmos
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Address
39467
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PhD Candidate
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
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Country
39467
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Australia
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Phone
39467
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+61 3 9903 0233
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Fax
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Email
39467
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[email protected]
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Contact person for scientific queries
Name
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Ms Emma Halmos
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Address
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PhD Candidate
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
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Country
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Australia
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Phone
39468
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+61 3 9903 0233
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Fax
39468
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Email
39468
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[email protected]
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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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