Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000691145
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
8/05/2019
Date last updated
2/07/2021
Date data sharing statement initially provided
8/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating fibres on gut health in Irritable Bowel Syndrome
Scientific title
ENOUGH IBS: Evaluating Novel Uses of fibres on Gut Health in Irritable Bowel Syndrome
Secondary ID [1] 298161 0
None
Universal Trial Number (UTN)
Trial acronym
ENOUGH IBS
Linked study record
Pilot study: ACTRN12618002042224

Health condition
Health condition(s) or problem(s) studied:
Gut Diseases 312460 0
Irritable Bowel Syndrome 312461 0
Condition category
Condition code
Oral and Gastrointestinal 311011 311011 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 311012 311012 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of two different dietary intervention periods lasting 14 days each. Participants will be provided with intervention diets during these periods consisting of three main meals (i.e. cereals, stir-fries, pastas) and 2-3 snack items (i.e. nuts, muffins) daily. The meals provided to participants are cooked in a commercial grade kitchen, pre-portioned, vacuum-sealed and frozen where appropriate.
Participants will be permitted to consume additional foods outside of their intervention diets, and will be provided with a recommended snack list to help guide food choices. These recommended food choices will contain limited fibre content in order to maintain adherence to the dietary interventions.
The average energy provided by the intervention diets is approximately 8000 kJ/d, with fibre content varying based on the type of dietary intervention:
* Diet 1: Approximately 31 g/d.
* Diet 2: Approximately 46 g/d (including 15 g/d resistant starch).
Participants will be provided with food records to assess adherence to the dietary interventions.
* A minimum 21-day washout period will separate each intervention arm (including control).

Two other periods will take place prior to the first dietary (either intervention or control). During these periods, participants will consume their normal, habitual diets. No intervention products will be provided
* Screening (5 days): Symptom assessment only, prior to inclusion (described under Eligibility)
* Baseline (7 days): Assessment of outcome measures at baseline, following inclusion
Intervention code [1] 314242 0
Lifestyle
Comparator / control treatment
A control intervention will consist of a dietary intervention lasting 14 days. Participants will be provided with an intervention diet during this period consisting of three main meals (breakfast, lunch and dinner) and 2-3 snack items daily. The meals provided to participants are cooked in a commercial grade kitchen, pre-portioned, vacuum-sealed and frozen where appropriate.
Participants will be permitted to consume additional foods outside of their intervention diets, and will be provided with a recommended snack list to help guide food choices and maintain adherence to the dietary intervention.
The average energy and fibre content of this diet is approximately 8000 kJ/d and 21 g/d respectively.
Participants will be provided with food records to assess adherence to the dietary interventions.
A minimum 21-day washout period will separate each intervention arm (including control).
Control group
Dose comparison

Outcomes
Primary outcome [1] 319948 0
Total faecal output (total weight in grams).
Timepoint [1] 319948 0
Total faecal output will be collected over the final five days of the baseline period and each dietary intervention period.
Secondary outcome [1] 370041 0
Faecal pH.
Timepoint [1] 370041 0
Total faecal output will be collected over the final five days of the baseline period and each dietary intervention period.
Secondary outcome [2] 370042 0
Faecal short chain fatty acid concentrations.
Timepoint [2] 370042 0
Total faecal output will be collected over the final five days of the baseline period and each dietary intervention period.
Secondary outcome [3] 370043 0
Stool consistency.
Timepoint [3] 370043 0
Total faecal output will be collected over the final five days of the baseline period and each dietary intervention period.
Secondary outcome [4] 370044 0
Faecal calprotectin.
Timepoint [4] 370044 0
Total faecal output will be collected over the final five days of the baseline period and each dietary intervention period.
Secondary outcome [5] 370045 0
Faecal microbiota composition.
Timepoint [5] 370045 0
Assessed on the final day of the baseline period (day 7) and each dietary intervention periods (day 14).
Secondary outcome [6] 370046 0
Serum short chain fatty acid concentrations.
Timepoint [6] 370046 0
Assessed on day 1 of the baseline period. Assessed on day 9 of each dietary intervention period.
Secondary outcome [7] 370047 0
Regional GI transit time.
Timepoint [7] 370047 0
Assessed via SmartPill on day 9 of each dietary intervention period. This investigation will be performed in a subgroup of participants willing to participate.
Secondary outcome [8] 370048 0
Regional GI pH.
Timepoint [8] 370048 0
Assessed via SmartPill on day 9 of each dietary intervention period. This investigation will be performed in a subgroup of participants willing to participate.
Secondary outcome [9] 370049 0
Intestinal metabolite profiles.
Timepoint [9] 370049 0
Assessed via telemetric capsule on day 9 of each dietary intervention period. This investigation will be performed in a subgroup of participants willing to participate. This is an exploratory outcome.
Secondary outcome [10] 370050 0
Gastrointestinal symptoms (overall symptoms, abdominal pain, wind, abdominal bloating, satisfaction with stool consistency, tiredness and lethargy, nausea) assessed via 100 mm visual analogue scale.
This is a composite outcome.
Timepoint [10] 370050 0
Assessed daily throughout the baseline and intervention periods.
Secondary outcome [11] 370051 0
Gastrointestinal symptoms (severity score, bowel habit and site of pain) via the IBS-Symptom Severity Score questionnaire.
Timepoint [11] 370051 0
Assessed at the beginning (day 1) of the baseline period and end (day 14) of each intervention period.
Secondary outcome [12] 370052 0
Psychological indicies (daily fatigue levels) assessed via the D-FIS.
Timepoint [12] 370052 0
Assessed daily throughout the baseline and intervention periods.
Secondary outcome [13] 370053 0
Psychological indicies (depression and anxiety) assessed via the DASS.
Timepoint [13] 370053 0
Assessed at the beginning (day 1) of the baseline period and end (day 14) of each intervention period.

Eligibility
Key inclusion criteria
* IBS defined by ROME IV diganostic criteria.
Potential participants not been formally diagnosed with IBS but presenting with the clinical features of the condition (i.e. recurrent abdominal pain and associated changes to bowel habit) will be referred to an appropriate medical doctor (either study gastroenterologist or their general practitioner) for formal diagnosis based on ROME IV criteria.

* Currently symptomatic
Eligible participants will then be invited to undertake screening to evaluate their IBS symptoms over five days. Symptoms will be assessed via a 100-mm VAS, where 0 mm indicates no symptoms and 100 mm represents the worst symptoms experienced. Participants whose scores are at least 30 mm for overall symptoms on the VAS will be included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Consumption of a special diet (i.e. low FODMAP, vegan diet).
* Significant comorbidities (i.e. diabetes, chronic kidney disease).
* Use of antibiotic therapies in the month preceding study commencement.
* Consumption of prebiotics and probiotics in the month preceding study commencement.
* Use of medication that potentially affects GI transit (i.e. hypomotility agents, laxatives).
* Pregnancy or planning pregnancy.
* Current smoker.
* Unable to give written informed consent.

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 allocation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by a researcher not involved in screening or recruitment, using online randomisation software.
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
Includes screening period as described previously.
Includes a baseline period evaluating habitual characteristics of participants.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
The trial was stopped early as a result of: 1) planned interim analysis of primary endpoint showing larger than expected differences between the interventions with the completed participants at the time; and 2) disruptions to recruitment and data collection due to COVID-19 restrictions.
Date of first participant enrolment
Anticipated
13/05/2019
Actual
21/05/2019
Date of last participant enrolment
Anticipated
29/05/2020
Actual
7/07/2020
Date of last data collection
Anticipated
31/10/2020
Actual
26/10/2020
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13684 0
The Alfred - Prahran
Recruitment postcode(s) [1] 26374 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 302535 0
University
Name [1] 302535 0
Monash University
Country [1] 302535 0
Australia
Funding source category [2] 302673 0
Commercial sector/Industry
Name [2] 302673 0
Tamu Innovations
Country [2] 302673 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] 302446 0
None
Name [1] 302446 0
Address [1] 302446 0
Country [1] 302446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303185 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 303185 0
Ethics committee country [1] 303185 0
Australia
Date submitted for ethics approval [1] 303185 0
01/06/2018
Approval date [1] 303185 0
23/07/2018
Ethics approval number [1] 303185 0
12804

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

Contacts
Principal investigator
Name 92782 0
A/Prof Jane Muir
Address 92782 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 92782 0
Australia
Phone 92782 0
+61 3 9903 0274
Fax 92782 0
Email 92782 0
[email protected]
Contact person for public queries
Name 92783 0
Daniel So
Address 92783 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 92783 0
Australia
Phone 92783 0
+61 3 9903 0264
Fax 92783 0
Email 92783 0
[email protected]
Contact person for scientific queries
Name 92784 0
Daniel So
Address 92784 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 92784 0
Australia
Phone 92784 0
+61 3 9903 0264
Fax 92784 0
Email 92784 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?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
It is expected the data will be available immediately 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 the purposes of scientific research only.
How or where can data be obtained?
Access subject to approval 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
SourceTitleYear of PublicationDOI
EmbaseSupplementing Dietary Fibers With a Low FODMAP Diet in Irritable Bowel Syndrome: A Randomized Controlled Crossover Trial.2022https://dx.doi.org/10.1016/j.cgh.2021.12.016
Dimensions AIDetection of changes in regional colonic fermentation in response to supplementing a low FODMAP diet with dietary fibres by hydrogen concentrations, but not by luminal pH2023https://doi.org/10.1111/apt.17629
N.B. These documents automatically identified may not have been verified by the study sponsor.