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Trial registered on ANZCTR


Registration number
ACTRN12618002042224
Ethics application status
Approved
Date submitted
15/12/2018
Date registered
20/12/2018
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate how novel fibres affect gut health
Scientific title
Evaluating Novel Uses of fibres on Gut Health in Irritable Bowel Syndrome: A Pilot Study
Secondary ID [1] 295979 0
None
Universal Trial Number (UTN)
Trial acronym
ENOUGH IBS: A Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut Diseases 309492 0
Irritable Bowel Syndrome 310819 0
Condition category
Condition code
Oral and Gastrointestinal 308323 308323 0 0
Normal oral and gastrointestinal development and function
Oral and Gastrointestinal 308324 308324 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 309494 309494 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of three different dietary intervention periods lasting 9 days each. During these periods, participants will consume, in addition to their habitual diet, supplemental meals (e.g. cereals, granola) containing different types of dietary fibre (sugarcane fibre; resistant starch; and a fibre combination (sugarcane fibre ahd resistant starch) in a dose-escalating manner.
Three doses of fibre will be investigated in each intervention period. Each dose will last for 3 days. The daily fibre doses are as follows:
* Sugarcane fibre: 5g, 10g, 15g.
* Resistant starch: 10g, 15g, 20g.
* Fibre combination: 20g, 25g, 30g.
Meals will be provided for breakfast and afternoon tea daily in the forms of breakfast cereals and snacks respectively. The habitual diets of participants will be adjusted slightly: dietary advice will be provided so that daily fibre intake will be maintained around 20 to 25 grams per day for the duration of the intervention periods.
Participants will be provided with symptom diaries and food records to assess the impact of these meals on gastrointestinal function, as well as compliance.
A minimum 3-day washout period will separate each intervention arm.
Intervention code [1] 312308 0
Treatment: Other
Comparator / control treatment
Controls include the following:
A 3-day baseline period which will precede the first intervention period. This will establish baseline GI function and symptoms, and habitual dietary intake.
Dose comparisons for each fibre investigated.
Control group
Active

Outcomes
Primary outcome [1] 308454 0
Gastrointestinal symptoms.
Participants will complete symptom dairies, where the following gastrointestinal symptoms will be assessed via 100mm visual analogue scale (VAS): abdominal pain/discomfort; abdominal bloating; wind; tiredness and lethargy; nausea; and overall symptoms.
This is a composite primary outcome.
Timepoint [1] 308454 0
Symptom diaries will be completed daily throughout the baseline and dietary intervention periods.
Symptom scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.
Secondary outcome [1] 354993 0
Stool consistency.
Assessed via questionnaires incorporating the Bristol Stool Chart.
Timepoint [1] 354993 0
Questionnaires will be completed daily throughout the baseline and dietary intervention periods.
Scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.
Secondary outcome [2] 354994 0
Satiety.
Assessed via VAS.
Timepoint [2] 354994 0
On the third day of the baseline period.
Every third day of each dietary intervention period
Secondary outcome [3] 354995 0
Palatability of supplemental breakfasts.
Assessed via VAS.
Timepoint [3] 354995 0
On the third day of the baseline period.
Every third day of each dietary intervention period
Secondary outcome [4] 355101 0
Stool frequency assessed questionnaire incorporating Likert scales.
Timepoint [4] 355101 0
Questionnaires will be completed daily throughout the baseline and dietary intervention periods.
Scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.

Eligibility
Key inclusion criteria
Population A: IBS patients
* Inclusion criteria: IBS as defined by ROME IV diagnostic criteria.
Population B: Healthy controls.
* Inclusion criteria: Healthy adults aged = 18 - 65.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Both populations:
* Existing or history of organic gastrointestinal disease (i.e. ulcerative colitis, Coeliac disease).
* Significant comorbidities (i.e. diabetes, chronic kidney disease).
* Use of antibiotic therapies in the month preceding study enrolment.
* Consumption of pre- or probiotics in the month preceding study enrolment.
* Use of medication potentially affecting GI transit (i.e. hypomotility agents, laxatives).
* Pregnancy or planning pregnancy during study period.
* Current smoker.
* Those unable to provide informed consent.

Population B only:
* Existing IBS as defined by ROME IV diagnostic criteria.

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)
Via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by study investigators using online randomisation software.
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)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12727 0
The Alfred - Prahran
Recruitment postcode(s) [1] 25156 0
3004 - Melbourne
Recruitment postcode(s) [2] 25157 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 300573 0
University
Name [1] 300573 0
Monash University
Address [1] 300573 0
Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country [1] 300573 0
Australia
Funding source category [2] 301456 0
Commercial sector/Industry
Name [2] 301456 0
Tamu Innovations
Address [2] 301456 0
Tamu Innovations
R&D & Innovation Centre
Hub Southern Cross,
696 Bourke St
Melbourne VIC 3000
Country [2] 301456 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 301147 0
None
Name [1] 301147 0
Address [1] 301147 0
Country [1] 301147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301362 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 301362 0
Monash Research Office
26 Sports Walk, Monash University,
Wellington Road, Clayton VIC 3800
Ethics committee country [1] 301362 0
Australia
Date submitted for ethics approval [1] 301362 0
05/06/2018
Approval date [1] 301362 0
23/07/2018
Ethics approval number [1] 301362 0
12804

Summary
Brief summary
Different types of fibre support gut health in different ways. For example, in the large intestine, certain types of fibre are easily broken down by the gut bacteria (through a process called fermentation). Fermentation offers a number of benefits to gut health, but can lead to symptoms in people living with IBS. We have identified several novel types of dietary fibre possessing fermentation characteristics that may be both favourable for gut
health and suitable for people living with IBS.

The aims of this study are to evaluate the acceptability and tolerability these fibres, the manner that they affect and gut function and whether they are suitable for people living with IBS.

To answer these questions, we are asking for both healthy volunteers and those currently living with IBS to participate in a dietary intervention study. This study will involve consuming these novel fibres as part of a regular diet. We aim to recruit a total of 10 participants (5 healthy volunteers; 5 living with IBS).

This study will help us better understand how these novel fibres, paving the way for further, clinical trials involving these novel fibres to better understand their potential role in our diets. This study has been initiated by Associate Professor Jane Muir, Head of Translational Nutrition Sciences at the Department of Gastroenterology and will be conducted by Mr. Daniel So as part of his PhD studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86750 0
A/Prof Jane Muir
Address 86750 0
Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 86750 0
Australia
Phone 86750 0
+61 3 9903 0274
Fax 86750 0
Email 86750 0
jane.muir@monash.edu
Contact person for public queries
Name 86751 0
Mr Daniel So
Address 86751 0
Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 86751 0
Australia
Phone 86751 0
+61 3 9903 0264
Fax 86751 0
Email 86751 0
daniel.so@monash.edu
Contact person for scientific queries
Name 86752 0
Mr Daniel So
Address 86752 0
Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 86752 0
Australia
Phone 86752 0
+61 3 9903 0264
Fax 86752 0
Email 86752 0
daniel.so@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
It is expected the data will be available immediate following publication, with no end date.
Available to whom?
Academic institutions, for scientific research purposes only.
Available for what types of analyses?
Available for any type of analysis, for scientific research purposes only.
By what mechanism will data be made available?
Access subject to approvals by Principal Investigator.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable