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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Irritable Bowel Syndrome

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Oral and Gastrointestinal

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]

Treatment: Other

Comparator / control treatment

Placebo (glucose)

Control group

Placebo

Outcomes

Primary outcome [1]

Breath hydrogen - this will measure the amount of carbohydrate which is not absorbed in the small intestine.

Timepoint [1]

Day 2 of each study arm

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University, Vic 3800, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/09/2013

Ethics approval number [1]

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

Dr Jane Muir

Address

Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004

Country

Australia

Phone

+61 3 9903-0274

Fax

jane.muir@monash.edu

Contact person for public queries

Name

Caroline Tuck

Address

Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004

Country

Australia

Phone

+61 3 9903-0264

Fax

caroline.tuck@monash.edu

Contact person for scientific queries

Name

Caroline Tuck

Address

Department of Gastroenterology Central Clinical School Monash University
Level 6, The Alfred Centre 99 Commercial Road Prahran VIC 3004

Country

Australia

Phone

+61 3 9903-0264

Fax

caroline.tuck@monash.edu

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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Documents added automatically

No additional documents have been identified.

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