Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000176662
Ethics application status
Approved
Date submitted
11/02/2014
Date registered
12/02/2014
Date last updated
12/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of glucose to assist fructose absorption in various forms to eliminate symptoms in Irritable Bowel Syndrome (IBS) fructose malabsorbers
Scientific title
Use of glucose to assist fructose absorption in various forms to eliminate symptoms in Irritable Bowel Syndrome (IBS) fructose malabsorbers
Secondary ID [1] 284075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 291133 0
Condition category
Condition code
Diet and Nutrition 291474 291474 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breath hydrogen production and symptoms will be measured after drinking 6 different sugar solutions over 6 days (separated by at least 1 day in between, depending on symptoms).
The sugar solutions will be made up to 375ml with water, the sugars tested will include:
*Glucose- 50g in 375ml
*Sucrose- 50g in 375ml
*Fructose- 25g in 375ml
*Fructose- 25g + Glucose- 25g in 375ml
*Fructans- 10g in 375ml
*Fructans- 10g + Glucose- 25g in 375ml
Intervention code [1] 288764 0
Treatment: Other
Intervention code [2] 288778 0
Other interventions
Comparator / control treatment
Each subject will act as their own control.
Participants with IBS will be compared to a healthy control group.
Control group
Active

Outcomes
Primary outcome [1] 291453 0
Breath hydrogen production will be measured every 20 minutes for the first 4 hours after drinking the sugar solution. Following this, hourly breath samples will be collected for an additional 8 hours.
Breath samples are collected by participants breathing into a special mouthpiece connected to breath collection bags.
Prior to testing, participants were instructed how to take breath samples by connecting the mouth piece to the breath sample bag, inhale and exhale normally so that the breath sample bag was inflated fully, then seal the bag immediately so that minimal air escaped.
Each sample will be subsequently analysed by researchers to test for hydrogen production.
Timepoint [1] 291453 0
Breath hydrogen will be measured every 20 minutes for the first 4 hours after drinking the sugar solution, and subsequently hourly for the following 8 hours (total 12 hours).
Secondary outcome [1] 306808 0
Symptom production will be measured via two symptoms diaries (completed at bed time each day). One diary uses a Likert Scale, whilst the other uses a Visual Analogue Scale (VAS) which asks participants to rate the severity of their symptoms on a 100mm line. The diaries will include questions regarding bowel movements and frequency, abdominal pain and discomfort, wind, nausea, heartburn and tiredness/lethargy.
Possible risks, side effects and discomforts include some wind, bloating, abdominal pain and discomfort and a temporary (less than 24 hours) increase in the number of bowel actions. This is not expected to be any more than usual symptoms that IBS patients would experience.
Timepoint [1] 306808 0
Symptoms will be assessed at bedtime each day.

Eligibility
Key inclusion criteria
- Malabsorb a 35g dose of fructose with a breath hydrogen rise of above 15ppm from baseline considered a positive result, with results being no more than 3 months old. If results were older than this they were retested.
- Have a functional gastrointestinal disorder OR have no significant gastrointestinal symptoms,
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Other gastrointestinal disease (e.g., Crohn’s, Ulcerative colitis, Coeliac) or diabetes
- Pregnant or breastfeeding.
- Can not have taken antibiotics, probiotics or had colonoscopy preparation in the past 2 weeks.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
26/08/2013
Date of last participant enrolment
Anticipated
31/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288707 0
University
Name [1] 288707 0
Monash University
Country [1] 288707 0
Australia
Primary sponsor type
University
Name
Monash Univesity
Address
Department of Gastroenterology
Central Clinical School
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Prahran VIC 3004
Country
Australia
Secondary sponsor category [1] 287409 0
None
Name [1] 287409 0
Address [1] 287409 0
Country [1] 287409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290543 0
Alfred Hospital Ethics Commitee
Ethics committee address [1] 290543 0
Ethics committee country [1] 290543 0
Australia
Date submitted for ethics approval [1] 290543 0
Approval date [1] 290543 0
Ethics approval number [1] 290543 0

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

Contacts
Principal investigator
Name 46178 0
Dr Jane Muir
Address 46178 0
Department of Gastroenterology
Central Clinical School
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Prahran VIC 3004
Country 46178 0
Australia
Phone 46178 0
+61 3 9903-0274
Fax 46178 0
Email 46178 0
[email protected]
Contact person for public queries
Name 46179 0
Caroline Tuck
Address 46179 0
Department of Gastroenterology
Central Clinical School
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Prahran VIC 3004
Country 46179 0
Australia
Phone 46179 0
+61 3 9903-0264
Fax 46179 0
Email 46179 0
[email protected]
Contact person for scientific queries
Name 46180 0
Caroline Tuck
Address 46180 0
Department of Gastroenterology
Central Clinical School
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Prahran VIC 3004
Country 46180 0
Australia
Phone 46180 0
+61 3 9903-0264
Fax 46180 0
Email 46180 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.