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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
Scientific title
Pilot study assessing the effects of poorly absorbed sugars in enteral formula on colonic gas production in healthy subjects
Secondary ID [1] 282375 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enteral nutrition-associated diarrhoea 288957 0
Condition category
Condition code
Oral and Gastrointestinal 289291 289291 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 289407 289407 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287008 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 289401 0
Breath hydrogen after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
Timepoint [1] 289401 0
12 hours after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
Secondary outcome [1] 302400 0
Breath methane after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
Timepoint [1] 302400 0
12 hours after ingestion of lactulose, Isosource'Registered Trademark' HN and Isosource'Registered Trademark' 1.5
Secondary outcome [2] 302401 0
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
Timepoint [2] 302401 0
The day after ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
Secondary outcome [3] 302402 0
Consistency of bowel motions rated by the Bristol Stool Chart following ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN
Timepoint [3] 302402 0
The day following ingestion of lactulose, Isosource'Registered Trademark'1.5 and Isosource'Registered Trademark'HN

Eligibility
Key inclusion criteria
Healthy subjects or subjects with functional gut symptoms such as irritable bowel syndrome over the age of 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
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.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2013
Actual
3/04/2013
Date of last participant enrolment
Anticipated
21/04/2013
Actual
17/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287148 0
University
Name [1] 287148 0
Department of Gastroenterology, Central Clinical School, Monash University
Country [1] 287148 0
Australia
Primary sponsor type
University
Name
Department of Gastroenterology, Central Clinical School, Monash University
Address
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 285915 0
None
Name [1] 285915 0
Address [1] 285915 0
Country [1] 285915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289146 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 289146 0
Ethics committee country [1] 289146 0
Australia
Date submitted for ethics approval [1] 289146 0
30/01/2013
Approval date [1] 289146 0
03/04/2013
Ethics approval number [1] 289146 0
CF13/269 - 2013000108

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

Contacts
Principal investigator
Name 39466 0
Prof Peter Gibson
Address 39466 0
Head of Gastroenterology
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39466 0
Australia
Phone 39466 0
+61 3 9903 0189
Fax 39466 0
Email 39466 0
[email protected]
Contact person for public queries
Name 39467 0
Emma Halmos
Address 39467 0
PhD Candidate
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39467 0
Australia
Phone 39467 0
+61 3 9903 0233
Fax 39467 0
Email 39467 0
[email protected]
Contact person for scientific queries
Name 39468 0
Emma Halmos
Address 39468 0
PhD Candidate
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39468 0
Australia
Phone 39468 0
+61 3 9903 0233
Fax 39468 0
Email 39468 0
[email protected]

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

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