Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000513819
Ethics application status
Approved
Date submitted
16/03/2021
Date registered
3/05/2021
Date last updated
4/08/2022
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of Enzyme Rich Malt Extract on gut health symptoms of irritable bowel syndrome in adults
Scientific title
Influence of Enzyme Rich Malt Extract on gut health symptoms of irritable bowel syndrome in adults
Secondary ID [1] 303108 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 320202 0
Condition category
Condition code
Diet and Nutrition 318144 318144 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IBS affects approximately 11.2% population globally and imposes a heavy burden on individual and community. We are investigating whether the consumption of a malt extract will reduce the symptoms of IBS, improve overall health and quality of life.

In a randomised double-blind cross-over design, patients will be consume 15mL of either a malt extract or placebo with meals for a four-week period. Participants will consume the malt extract or placebo twice daily with meals at home and record consumption in a daily online survey. A six-week washout period will occur between conditions. Prior to and following the four-week intervention period, anthropometry (height and weight) will be determined. Participants will also complete a 3-day food diary using an online application at the same time points. Prior to, during and following the intervention, participants will be required to complete several questionnaires (illness/adverse events, dietary intake and stool consistency), provide stool (gut microbiome and its metabolites i.e short chain fatty acids) and fasting blood (gut permeability, metabolic profile, immune function markers) samples. Throughout the supplementation period participants will be encouraged to re-introduce foods that have trigged IBS in the past. The diet intervention and re-introduction of these foods will be guided by a trained nutritionist with more than 10 years' of experience and be entirely voluntarily. This reintroduction of foods will assess whether the supplementation has improved gut health to a point of lowering IBS related restrictions on the participants’ diet. The venous blood samples and stool samples will be collected at baseline and post-intervention by a trained phlebotomist. All questionnaires will be collated in the software REDCaps and, where possible, administered online to reduce participant burden and reduce data entry error. The daily questionnaire will also be used to monitor adherence to the intervention. However, if a participant prefers, questionnaires may be completed on hard copies and later transcribed to the online software.
Intervention code [1] 319412 0
Treatment: Other
Comparator / control treatment
Participants will consume a control placebo malt extract that has been heated to denature any enzymes that may be beneficial.
Control group
Placebo

Outcomes
Primary outcome [1] 326140 0
Change in IBS-related symptoms assessed with the Hunter IBS questionnaire and bowel symptom checklist
Timepoint [1] 326140 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [1] 390231 0
Change in gut microbiome as assessed by stool sample
Timepoint [1] 390231 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [2] 390232 0
Change in Stool consistency assessed with the Bristol stool chart
Timepoint [2] 390232 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [3] 390233 0
Change in Quality of Life via IBS-QOL questionnaire
Timepoint [3] 390233 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [4] 393999 0
Change in metabolomic profiles as measure with blood samples
Timepoint [4] 393999 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [5] 394000 0
Changes in anxiety assessed with the Nijmegen Anxiety Questionnaire
Timepoint [5] 394000 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [6] 394001 0
and interlukin-1beta (IL-1beta)
Timepoint [6] 394001 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [7] 394002 0
Changes in dietary habits assessed via a 3 day weighted food diary
Timepoint [7] 394002 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [8] 394003 0
Changes in anthropometric measures (i.e. height, weight) via laboratory scales and stadiometer
Timepoint [8] 394003 0
Baseline and following each of the 4 week placebo and malt extract diet interventions
Secondary outcome [9] 412565 0
Changes in diet and gut biomarkers lipopolysaccharide (LPS), serum amylase, glycated haemoglobin (HbA1c)
Timepoint [9] 412565 0
Baseline and post each of the 4-week placebo or malt extract treatment periods

Eligibility
Key inclusion criteria
Male and female participants will be between 18 - 65 years old and have been clinically diagnosed with IBS, meeting the Rome IV edition diagnostic criteria
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Smoking,
• Pregnancy or planning to become pregnant,
• Breastfeeding,
• Having a known diagnosis of other gastrointestinal illness (e.g. Inflammatory Bowel Disease, malabsorption of any macronutrients, bowel resection, coeliac disease),
• Previous abdominal or gastrointestinal surgeries, severe mental health and sleep-related conditions (e.g. insomnia), renal or hepatic diseases, and major medical illness,
• Current use of pharmaceutical agents that could modify or treat IBS (e.g. probiotics, antibiotics, eluxadoline, lubiprostone and linaclotide),
• Other restrictive dietary patterns or therapies (e.g. gluten-free, low-carbohydrate, or high-protein diets, keto/Paleo-diet),
• Taken antibiotics or prebiotics in the past 6 weeks,
• Any other known disease, condition or habit that may interfere with completion of study.

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
17/05/2021
Actual
24/05/2021
Date of last participant enrolment
Anticipated
Actual
24/09/2021
Date of last data collection
Anticipated
Actual
28/02/2022
Sample size
Target
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307512 0
Commercial sector/Industry
Name [1] 307512 0
Ateria Health
Country [1] 307512 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 308816 0
None
Name [1] 308816 0
Address [1] 308816 0
Country [1] 308816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307584 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 307584 0
Ethics committee country [1] 307584 0
Australia
Date submitted for ethics approval [1] 307584 0
20/11/2020
Approval date [1] 307584 0
25/01/2021
Ethics approval number [1] 307584 0
2020-02097-ABBISS

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

Contacts
Principal investigator
Name 107762 0
A/Prof Chris R. Abbiss
Address 107762 0
Edith Cowan University, Office JO21.512, 270 Joondalup Drive, Joondalup, WA, 6027
Country 107762 0
Australia
Phone 107762 0
+61404299331
Fax 107762 0
Email 107762 0
[email protected]
Contact person for public queries
Name 107763 0
Dr. Joanna Rees
Address 107763 0
Edith Cowan University, Office JO21.108, 270 Joondalup Drive, Joondalup, WA, 6027
Country 107763 0
Australia
Phone 107763 0
+61404299331
Fax 107763 0
Email 107763 0
[email protected]
Contact person for scientific queries
Name 107764 0
Chris R. Abbiss
Address 107764 0
Edith Cowan University, Office JO21.512, 270 Joondalup Drive, Joondalup, WA, 6027
Country 107764 0
Australia
Phone 107764 0
+61404299331
Fax 107764 0
Email 107764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected for the purposes of this research project (aside from identifying information) may be used in further approved research projects at the discretion of the Principle Investigator
When will data be available (start and end dates)?
Following the conclusion of this study (30-12-2022) with no end date
Available to whom?
Researchers who are conducting approved research projects at the discretion of the primary investigator.
Available for what types of analyses?
For any purpose of further approved research projects
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.