Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000711415p
Ethics application status
Submitted, not yet approved
Date submitted
13/11/2024
Date registered
4/07/2025
Date last updated
4/07/2025
Date data sharing statement initially provided
4/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of FODMAP enzymes to treat symptoms in patients with irritable bowel syndrome
Scientific title
Evaluation of FODMAP enzymes to treat symptoms in patients with irritable bowel syndrome
Secondary ID [1] 313375 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
irritable bowel syndrome 335744 0
Condition category
Condition code
Diet and Nutrition 332299 332299 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 333163 333163 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
This study is a 1 week cross-over feeding trial using a FODMAP enzyme. This will involve consumption of 3 Intoleran Quatrase enzymes in oral capsule form with each provided meal and snack for 1 week. Participants will be expected to consume the capsules with their meals. Food and enzyme diaries will be kept during the week.
The wash out period between the two interventions will be a minimum of 3 weeks.
Intervention code [1] 329957 0
Treatment: Other
Comparator / control treatment
This study is a 1 week cross-over feeding trial using a glucose-based placebo pill. This will involve consumption of 3 identical oral capsules with each provided meal and snack for 1 week. Food and enzyme diaries will be kept during the week.
Control group
Placebo

Outcomes
Primary outcome [1] 339876 0
IBS symptoms at the end of intervention
Timepoint [1] 339876 0
Day 7 of the intervention and placebo
Secondary outcome [1] 441730 0
Quality of life at the end of intervention
Timepoint [1] 441730 0
Day 7 of the intervention and placebo
Secondary outcome [2] 444893 0
Breath hydrogen at the start and end of interventions
Timepoint [2] 444893 0
the day before start of intervention and placebo and the last day of intervention and placebo
Secondary outcome [3] 444894 0
Psychological indices included anxiety, stress and depression
Timepoint [3] 444894 0
At the end of both interventions (day 7)
Secondary outcome [4] 445538 0
markers intestinal barrier function
Timepoint [4] 445538 0
study conclusion (6 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Meet the ROME IV criteria for IBS and reported good symptoms control on a low FODMAP diet
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
any organic gastrointestinal condition, patients on restrictive diets (excluding FODMAP) who are unable to consume the provided diet, supplementary prebiotics or probiotics, pregnant or breastfeeding, inability to speak or read English

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317818 0
Commercial sector/Industry
Name [1] 317818 0
Intoleran
Country [1] 317818 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320147 0
Hospital
Name [1] 320147 0
Alfred Health
Address [1] 320147 0
Country [1] 320147 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316501 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316501 0
Ethics committee country [1] 316501 0
Australia
Date submitted for ethics approval [1] 316501 0
12/12/2024
Approval date [1] 316501 0
Ethics approval number [1] 316501 0
Ethics committee name [2] 316502 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 316502 0
Ethics committee country [2] 316502 0
Australia
Date submitted for ethics approval [2] 316502 0
01/05/2025
Approval date [2] 316502 0
Ethics approval number [2] 316502 0

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

Contacts
Principal investigator
Name 138094 0
Miss Ellen Anderson
Address 138094 0
School of Translational Science, Monash University, Level 6, 99 Commerical Road, Melbourne VIC 3004
Country 138094 0
Australia
Phone 138094 0
+61 400199981
Fax 138094 0
Email 138094 0
[email protected]
Contact person for public queries
Name 138095 0
Ellen Anderson
Address 138095 0
School of Translational Science, Monash University, Level 6, 99 Commerical Road, Melbourne VIC 3004
Country 138095 0
Australia
Phone 138095 0
+61 400199981
Fax 138095 0
Email 138095 0
[email protected]
Contact person for scientific queries
Name 138096 0
Ellen Anderson
Address 138096 0
School of Translational Science, Monash University, Level 6, 99 Commerical Road, Melbourne VIC 3004
Country 138096 0
Australia
Phone 138096 0
+61 400199981
Fax 138096 0
Email 138096 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.