ANZCTR - Registration

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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

25/11/2019

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]

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

Irritable Bowel Syndrome

Condition category

Condition code

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Diet and Nutrition

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]

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]

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]

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]

Stool consistency.
Assessed via questionnaires incorporating the Bristol Stool Chart.

Timepoint [1]

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]

Satiety.
Assessed via VAS.

Timepoint [2]

On the third day of the baseline period.
Every third day of each dietary intervention period

Secondary outcome [3]

Palatability of supplemental breakfasts.
Assessed via VAS.

Timepoint [3]

On the third day of the baseline period.
Every third day of each dietary intervention period

Secondary outcome [4]

Stool frequency assessed questionnaire incorporating Likert scales.

Timepoint [4]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

2/01/2019

Actual

3/01/2019

Date of last participant enrolment

Anticipated

31/01/2019

Actual

10/04/2019

Date of last data collection

Anticipated

31/03/2019

Actual

29/05/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Tamu Innovations

Address [2]

Tamu Innovations
R&D & Innovation Centre
Hub Southern Cross,
696 Bourke St
Melbourne VIC 3000

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Commitee

Ethics committee address [1]

Monash Research Office
26 Sports Walk, Monash University, 
Wellington Road, Clayton VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2018

Approval date [1]

23/07/2018

Ethics approval number [1]

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

A/Prof Jane Muir

Address

Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004

Country

Australia

Phone

+61 3 9903 0274

Fax

jane.muir@monash.edu

Contact person for public queries

Name

Daniel So

Address

Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004

Country

Australia

Phone

+61 3 9903 0264

Fax

daniel.so@monash.edu

Contact person for scientific queries

Name

Daniel So

Address

Department of Gastroenterology.
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004

Country

Australia

Phone

+61 3 9903 0264

Fax

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.

How or where can data be obtained?

Access subject to approvals by Principal Investigator.

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

Source	Title	Year of Publication	DOI
Embase	Evaluating tolerability of resistant starch 2, alone and in combination with minimally fermented fibre for patients with irritable bowel syndrome: A pilot randomised controlled cross-over trial.	2022	https://dx.doi.org/10.1017/jns.2022.9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically