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Trial registered on ANZCTR


Registration number
ACTRN12615000489594
Ethics application status
Approved
Date submitted
29/04/2015
Date registered
18/05/2015
Date last updated
10/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of oral enzymes for the treatment of carbohydrate intolerance in Irritable Bowel Syndrome.
Scientific title
Evaluation of the efficacy of oral enzymes for the treatment of carbohydrate intolerance in Irritable Bowel Syndrome.
Secondary ID [1] 286604 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 294913 0
Condition category
Condition code
Diet and Nutrition 295161 295161 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 295229 295229 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
Breath hydrogen and symptoms will be measured on 3 different study arms. Each arm involves 3 days of consuming foods provided (low in FODMAPs but high in Galactooligosaccharides) plus an oral enzyme supplement. The food will be identical for each study arm. The food is low in FODMAPs meaning it does not contain foods classified as high FODMAP according to the Monash University low FODMAP diet with the exception of foods high in galactooligosaccharides. Types of foods high in galactooligosaccharides include nuts, legumes and lupin flakes which have been used in the study diet. The maximum total FODMAP content (mainly coming from the galactooligosaccharides) in the diet per day is 7g.
In between the study arms there will be at least a 3 day washout period.
Breath hydrogen will be measured hourly for 12 hours on the 2nd day of each study arm.
Symptoms will be measured once daily at bed time each day.
An oral enzyme supplement (alpha-galactosidase) in 2 doses or placebo will be given with each study arm. The supplement will be given three times daily (with each meal) for the 3 days of each study arm. The enzyme or placebo for each arm will be given in a random order to participants, but will include:
*Placebo will be 2 glucose tablets. I.e. no dose.
*Half dose will be 1 enzyme (containing 300 galU) and 1 glucose tablet.
*Full dose will be 2 enzyme tablets (containing total 600 galU).
Tablets will all look the same to aid in blinding.
Participants will be asked to return their tablet containers to assist in monitoring adherence.
Intervention code [1] 291728 0
Treatment: Other
Comparator / control treatment
Placebo (glucose)
Control group
Placebo

Outcomes
Primary outcome [1] 294923 0
Breath hydrogen - this will measure the amount of carbohydrate which is not absorbed in the small intestine.
Timepoint [1] 294923 0
Day 2 of each study arm
Secondary outcome [1] 314360 0
Gastrointestinal symptoms - these will be measured using a 100mm visual analogue scale as well as a 3 point likert scale.
Types of symptoms that will be measured include:
*Overall Symptoms
*Abdominal pain
*Abdominal bloating
*Wind
*Tiredness and lethargy
*Nausea
*Heartburn
Timepoint [1] 314360 0
Day 3 of each study arm

Eligibility
Key inclusion criteria
People with Irritable Bowel Syndrome, as assessed by Rome III criteria, but otherwise well.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*People with other diagnosed gastrointestinal disorders such as Coeliac Disease and IBD.
*Non-hydrogen producers as shown on Fructan breath hydrogen test.
*Women who are pregnant or breastfeeding.
*Those with known food allergy likely to affect ability to follow study dietary protocol.
*Those who have taken antibiotics, probiotics or prebiotics within the 4 weeks prior to the study.
*Colonoscopy (bowel prep) within the past 4 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/04/2015
Date of last participant enrolment
Anticipated
Actual
30/04/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291174 0
Government body
Name [1] 291174 0
NHMRC
Country [1] 291174 0
Australia
Primary sponsor type
University
Name
Monash University
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] 289854 0
None
Name [1] 289854 0
Address [1] 289854 0
Country [1] 289854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292747 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292747 0
Monash University, Vic 3800, Australia
Ethics committee country [1] 292747 0
Australia
Date submitted for ethics approval [1] 292747 0
Approval date [1] 292747 0
25/09/2013
Ethics approval number [1] 292747 0
CF13/2060 - 2013001029

Summary
Brief summary
Irritable bowel syndrome (IBS) is a common disorder affecting 5-15% of Australians. Recently the Gastroenterology department research team at Monash University have created a dietary management approached for the treatment of IBS. The dietary approach termed the low FODMAP diet restricts poorly absorbed carbohydrates. The term FODMAPs denotes fermentable, oligo-, di-, mono-saccharides and polyols. These carbohydrates are poorly absorbed in the small intestinal lumen and therefore travel to the large intestine where they are fermented by colonic bacteria to produce products of hydrogen, methane, carbon dioxide and short chain fatty acids. The dietary approach uses a restrictive phase followed by a re-introduction phase to assess individual tolerance to the various FODMAP subgroups. The dietary restrictions however can be difficult to maintain, especially among patients with other food intolerances or dislikes. This is particularly relevant to vegetarians and vegans as legumes, a major source of protein, is restricted during the low FODMAP diet. The types of carbohydrates in legumes are unable to be digested in the human small intestine as humans do not have the enzyme to break them down; they are therefore often a trigger of IBS symptoms. In the USA and Europe there are tablets on the market which contain alpha-galactosidase, an enzyme to break down the carbohydrate’s present in legumes. A few studies have been conducted to assess the enzyme use in healthy controls, but there is limited research using them in patients with IBS.
The aim of this study is to evaluate if the alpha-galactosidase enzyme can reduce breath hydrogen and symptoms in IBS. We hypothesize that there will be a reduction in both hydrogen and symptoms with the use of the alpha-galactosidase enzyme.
Trial website
http://www.med.monash.edu/cecs/gastro/clin-trials/index.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56838 0
Dr Jane Muir
Address 56838 0
Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004
Country 56838 0
Australia
Phone 56838 0
+61 3 9903-0274
Fax 56838 0
Email 56838 0
[email protected]
Contact person for public queries
Name 56839 0
Caroline Tuck
Address 56839 0
Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004
Country 56839 0
Australia
Phone 56839 0
+61 3 9903-0264
Fax 56839 0
Email 56839 0
[email protected]
Contact person for scientific queries
Name 56840 0
Caroline Tuck
Address 56840 0
Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004
Country 56840 0
Australia
Phone 56840 0
+61 3 9903-0264
Fax 56840 0
Email 56840 0
[email protected]

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