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Trial registered on ANZCTR


Registration number
ACTRN12613000501741
Ethics application status
Approved
Date submitted
24/04/2013
Date registered
7/05/2013
Date last updated
7/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of carbohydrates of differing molecular-size on diarrhoea-predominant irritable bowel syndrome (IBS-D)
Scientific title
Effects of carbohydrates of differing molecular-size on faecal water content, gastrointestinal symptoms and breath hydrogen in patients with IBS-D
Secondary ID [1] 282396 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 288976 0
Condition category
Condition code
Oral and Gastrointestinal 289316 289316 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
Participants will ingest the following single dose solutions fasted (on waking) in a random order with a minimum of three day washout period before crossing over to all of the other solutions:
Arm 1 - 20g Lactulose in 100mL solution
Arm 2 - 20g Fructo-oligosaccharide in 100mL solution
Arm 3 - 20g Inulin in 100mL solution
Arm 4 - 20g Glucose in 100mL solution
Intervention code [1] 287029 0
Treatment: Other
Comparator / control treatment
Glucose is the negative control and lactulose is the positive control. 15g is usually given as a dose for a positive control for symptoms and breath hydrogen production. 20g is given in this study to ensure the participants get symptoms on the lactulose positive control. The other sugars provided are of the same dose for comparison.
Control group
Active

Outcomes
Primary outcome [1] 289430 0
Faecal water content after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions. This will be determined via comparing weight of faecal sample before and after freeze-drying, which will remove water from the sample.
Timepoint [1] 289430 0
24 hours after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions
Secondary outcome [1] 302455 0
Severity of overall gut symptoms and specific symptoms of bloating, pain and loose bowel motions after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions as measured by a 100 mm visual analogue scale.
Timepoint [1] 302455 0
Rated at the end of the day after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions
Secondary outcome [2] 302456 0
Consistency of bowel motions after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions as rated by the Bristol Stool Chart
Timepoint [2] 302456 0
Each bowel motion for 24 hours after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions
Secondary outcome [3] 302457 0
Breath hydrogen after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions. Participants will collect breath samples at 15 minute intervals for four hours after ingestion of the sugars in supplied breath-collection bags. The stored breath will be measured for hydrogen content using a 'breathtracker' instrument.
Timepoint [3] 302457 0
Collected for 4 hours after ingestion of lactulose, fructo-oligosaccharide, inulin and glucose solutions

Eligibility
Key inclusion criteria
Patients with diarrhoea-predominant irritable bowel syndrome with reported good symptom control while following a low FODMAP diet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Organic disease or condition predisposing the patient to diarrhoea (e.g. coeliac disease, inflammatory bowel disease, bowel resection)
2. Use of antidiarrhoeal medications for one week prior to study commencement
3. Probiotic or prebiotic use for two weeks prior to study commencement
4. Antibiotic use for two weeks prior to study commencement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from a private dietetics practice. The director and dietitian of the company will email patients diarrhoea-predominant irritable bowel syndrome previously seen at the practice for a low FODMAP diet as therapy. Patients interested in the study will contact a study investigator for assessment of eligibility. If eligible, the participant will be randomly allocated the order of which sugar solutions they will receive. The allocation will be determined by a computer-generated order for the participant to receive 'Solution A', 'Solution B', 'Solution C' and 'Solution D' in random order. The study investigators will administer the solutions to the participants but the labeling of solutions will be conducted by one persion who is not a study investigator. This way, both the participant and study investigators will be blinded to the sugar solutions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation will be used. The cross-over study design means all participants will ingests all four sugar solutions.
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
Safety/efficacy
Statistical methods / analysis
Appropriate ANOVA testing to compare multiple observations.

There is no known previously published data investigating the primary endpoint of faecal water content in patients with IBS-D. Sample size was therefore based on the secondary endpoint of gastrointestinal symptoms. Based on published data in IBS patients ingesting both fructan and glucose solutions, 18 patients will detect a 63% increase in reported ‘adequately controlled symptoms’ on the glucose solution, assuming 77% of IBS patients will not have reported ‘adequately controlled symptoms’ on similar dose of fructan ingestion. This sample size is based on 80% power and p-value of 0.05. Allowing a drop-out rate of 20%, then 25 participants will need to be recruited for the study. Interim analysis for the primary endpoint will be completed on 25 participants to determine require of more participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2013
Actual
Date of last participant enrolment
Anticipated
31/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287171 0
University
Name [1] 287171 0
Monash University
Country [1] 287171 0
Australia
Primary sponsor type
University
Name
Department of Gastroenterology, Central Clinical School, Monash University
Address
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 285936 0
None
Name [1] 285936 0
None
Address [1] 285936 0
None
Country [1] 285936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289167 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 289167 0
Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [1] 289167 0
Australia
Date submitted for ethics approval [1] 289167 0
14/02/2013
Approval date [1] 289167 0
18/04/2013
Ethics approval number [1] 289167 0
CF13/477 - 2013000207

Summary
Brief summary
The low FODMAP diet is effective in managing symptoms in many patients with irritable bowel syndrome. To assess if liberalisation of the diet is possible while still maintaining good symptom control, it is hypothesised that longer-chain FODMAP sugars (inulin) is less fermentable and less osmotic in the large intestine and will therefore not contribute to symptoms as much as shorter-chain FODMAPs (fructo-oligosaccharides and lactulose). Glucose is not a FODMAP, but a sugar that is well absorbed and it is hypothesised that glucose will not contribute to symptoms.
Diarrhoea-predominant patients with reported good symptom control on a low FODMAP diet will be recruited for easier measuring of symptom change, bowel motions and faecal water content specifically.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39550 0
Dr Jane Muir
Address 39550 0
Head of Translational Nutrition Science
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39550 0
Australia
Phone 39550 0
+61 3 9903 0147
Fax 39550 0
Email 39550 0
[email protected]
Contact person for public queries
Name 39551 0
Frances Burns
Address 39551 0
Honours Student
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39551 0
Australia
Phone 39551 0
+61 3 9903 0396
Fax 39551 0
Email 39551 0
[email protected]
Contact person for scientific queries
Name 39552 0
Emma Halmos
Address 39552 0
PhD Candidate
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 39552 0
Australia
Phone 39552 0
+61 3 9903 0233
Fax 39552 0
Email 39552 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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