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Trial registered on ANZCTR

Registration number

ACTRN12624000551594

Ethics application status

Approved

Date submitted

9/04/2024

Date registered

1/05/2024

Date last updated

25/07/2024

Date data sharing statement initially provided

1/05/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Pilot testing of an online fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) intervention for adults with irritable bowel syndrome

Scientific title

Proof of concept, feasibility and acceptability of an online FODMAP intervention for adults with irritable bowel syndrome.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Irritable bowel syndrome

Condition category

Condition code

Oral and Gastrointestinal

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The online diet program is based on an evidence-based diet, recommended as first or second line therapy in irritable bowel syndrome. The diet is the low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides and polyols) diet. It is a 3-phase diet which involves:
• Phase 1 FODMAP restriction – restricting foods high or moderate in fructans (e.g., wheat products, onions), galacto-oligosaccharides (e.g., legumes), lactose (e.g., cows’ milk), excess fructose (e.g., honey), and polyols (e.g., pear, sugar-free gum); and swapping these for low FODMAP alternatives.
• Phase 2 FODMAP reintroduction – continuing to follow a low FODMAP diet and completing a series of food challenges to help understand which foods and FODMAPs are tolerated and which trigger symptoms
• Phase 3 FODMAP personalisation – including well tolerated foods and FODMAPs back into the diet, while restricting poorly tolerated foods and FODMAPs to a level needed to maintain symptom relief.
The online diet program is a self-directed program implemented over 12 weeks, with an online therapist (dietitian) to guide participants through the program. The content of the online FODMAP diet program is organised into six Steps to be completed over the 12-week program duration and is delivered via the e-learning platform CANVAS. Participants are provided with a link to the CANVAS platform (and access to the online diet program) by the primary researcher. The program provides all the information that participants require to follow the 3-phase FODMAP diet. They are not provided with any food or meals as part of the online diet education program.
Participants access each Step individually. They are instructed to complete one module per week over the 12-week course (i.e. 12 modules). The first two Steps are completed in weeks 1 and 2 (module 1 and 2). Step 1 provides a background understanding of IBS and the FODMAP diet and Step 2 describes Phase 1 of the FODMAP diet. Steps 3, 4 and 5 describe and guide participants through the implementation of the 3-phase FODMAP diet (Phase 1 restriction; Phase 2 reintroduction; and Phase 3 personalisation). Step 3 is completed weeks 3-6 (modules 3-6) and Steps 4 and 5 are completed weeks 7-11 (modules 7-11) of the program. Step 6 of the program is completed in the final week (week 12 - module 12) and provides information to empower participants to manage their IBS and their personalised FODMAP diet after the online program is finished.
Each Step of the program consists of information provided as text, image-based information, and as downloadable handouts/worksheets. Some steps also include interactive activities (e.g. written reflection prompts, draggable questions and knowledge check questions). At the completion of each module participants will be directed to complete homework activities and questions and submit to the dietitian for feedback. Submission of homework activities and questions is required for access to successive modules. If participants do not complete a module and/or submit related homework, the program administrator (study primary researcher) will send a reminder one day and four days after the recommended date of completion. Participants will also be able to ask the dietitian questions at any time throughout the program. The therapist (dietitian) will respond to participant homework activities and questions within 2 days of submission. Feedback provided will be guided by a response message bank developed a priori by the primary researcher (JA) and the online therapist (dietitian) for the feasibility study.

Intervention code [1]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Gastrointestinal irritable bowel syndrome (IBS) symptoms

Timepoint [1]

Assessed at the end of week 6 of the 12-week diet intervention.

Primary outcome [2]

Total fructooligosaccharide, oligosaccharide, monosaccharide and polyol (FODMAP) intake

Timepoint [2]

4-day food diary completed in week 6 of the online diet intervention.

Primary outcome [3]

Online program feasibility benchmark - Completion of primary measure

Timepoint [3]

Completion of primary measures- IBS Symptom Severity Score (IBS-SSS) at baseline and weeks 2, 4, 6, 8, 10, and 12 of the online diet intervention.

Secondary outcome [1]

Program acceptability.

Timepoint [1]

Post 12-week online diet program.

Secondary outcome [2]

Gastrointestinal symptoms

Timepoint [2]

Weekly completion of Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) during the 12-week diet intervention.

Secondary outcome [3]

Gastrointestinal specific anxiety

Timepoint [3]

Second weekly completion of questionnaires i.e. baseline and weeks 2, 4, 6, 8, 10, 12 of the online diet intervention.

Secondary outcome [4]

Somatic symptoms

Timepoint [4]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [5]

Program completion

Timepoint [5]

Weekly assessment (12-week intervention)

Secondary outcome [6]

Primary Outcome: Online program feasibility benchmark - Completion of primary measure

Timepoint [6]

Primary Timepoint: Completion of composite primary measure- 4-day food diary at baseline and weeks 2, 4, and 6; and Comprehensive Nutrition Assessment Questionnaire (CNAQ) at 2 timepoints during the study i.e. weeks 9 and 12 of the online diet intervention.

Secondary outcome [7]

Primary Outcome: Online program feasibility benchmark – Program engagement

Timepoint [7]

Primary timepoint: Program engagement - data records from online platform CANVAS collected during 12-week online program.

Secondary outcome [8]

Primary Outcome: Online program feasibility benchmark – Dietitian intervention

Timepoint [8]

Primary timepoint: Dietitian intervention - data records from online platform CANVAS and dietitian records collected during 12-week online program.

Secondary outcome [9]

Primary Outcome: Online program feasibility benchmark - Acceptability

Timepoint [9]

Primary timepoint: Acceptability -questionnaire via 5-pt Likert scale completed post completion of 12-week online program.

Secondary outcome [10]

Gastrointestinal Symptoms

Timepoint [10]

Weekly completion of completion of IBS Symptom Severity Score (IBS-SSS) questionnaire during the 12-week diet intervention.

Secondary outcome [11]

Food avoidance behaviour

Timepoint [11]

Second weekly completion of questionnaires i.e. baseline and weeks 2, 4, 6, 8, 10, 12 of the online diet intervention.

Secondary outcome [12]

Depression

Timepoint [12]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [13]

Anxiety

Timepoint [13]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [14]

Quality of life.

Timepoint [14]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [15]

Food and eating behaviour

Timepoint [15]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [16]

Avoidant/restrictive food behaviour

Timepoint [16]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [17]

Physical activity

Timepoint [17]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Secondary outcome [18]

Illness perception

Timepoint [18]

Baseline, mid treatment (week 6) and end of treatment (week 12)

Eligibility

Key inclusion criteria

Adults aged 18 years or older with self-reported IBS which meets ROME IV criteria. Potential participants must be symptomatic at time of recruitment as indicated by a symptom severity score >75 measured using the IBS-SSS (IBS Symptom Severity Score)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Presence or known history of other GI diseases i.e. coeliac disease or inflammatory bowel disease) or history of major GI surgery (except appendectomy or haemorrhoidectomy).
• Presence of major comorbidities that could explain current gastrointestinal symptoms i.e. severe diabetic, cardiac, liver, neurological, neuropathy disease.
• Alarm symptoms (e.g. blood in stool, rapid weight loss, nocturnal symptoms, recent change in bowel habits if >50 years) shown to predict presence of organic diseases.
• Less than 2 years of IBS symptoms regardless of when diagnosis given
• History or current diagnosis of anorexia nervosa, binge eating disorder or bulimia nervosa). Participants with avoidant/restrictive food intake disorder (ARFID) or milder forms of disordered eating may be included.
• History or current diagnosis of psychotic disorder or bipolar disorder; current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation.
• Body Mass Index (BMI) < 18.5kg/m2
• Pregnant or lactating or plans to become pregnant during study duration
• Currently on a restriction/elimination diet for gastrointestinal symptoms (e.g. low FODMAP diet, gluten free diet) or have undertaken the 3-phase low FODMAP diet delivered by a dietitian within the last two years. Those following a lactose free diet will be eligible if they agree to keep intake consistent unless advised to reduce further.
• Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure)
• Currently undertaking brain-gut behaviour therapy (e.g. gut-directed hypnotherapy; gut-directed psychotherapy; mindfulness-based stress reduction; mindfulness-based cognitive therapy). Participants engaged in regular stress reduction activities such as breathing exercises, psychology counselling, mindfulness, and/or physical activity will be encouraged to continue with these activities during the 12-week intervention program.
• Commenced or change in dose of IBS medications (e.g. antidepressants) in the three months preceding study commencement.
• Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrhoeals and laxatives) in the month preceding study commencement. Supplements such as probiotics, prebiotics, fibre supplements and digestive enzymes will be allowed, provided that participants have been on a stable dose for at least 1 month before inclusion.
• Not willing to change current diet or dietary supplement intake (e.g. fibre supplements)
• No access to internet or computer
• Insufficient language or computer skills to complete a text based online treatment.
• Inability to provide informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised 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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

20/03/2024

Date of last participant enrolment

Anticipated

31/05/2024

Actual

23/03/2024

Date of last data collection

Anticipated

6/09/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

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 Committee

Ethics committee address [1]

https://www.monash.edu/researchoffice/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/12/2023

Approval date [1]

03/01/2024

Ethics approval number [1]

38218

Summary

Brief summary

The aim of this research project is to evaluate proof of concept - change in mechanistic and clinical outcomes, and feasibility and acceptability of a newly developed online FODMAP (LFD) diet intervention. The FODMAP diet is an evidence-based therapy and first-line intervention for the management of IBS.
The specific aims of this research are:
To evaluate if the online FODMAP diet program can achieve a pre-specified minimally clinically important change (MCIC) in:
    i.	Total FODMAP intake; and
    ii.	Gastrointestinal IBS symptoms.
To evaluate if the online FODMAP diet program can be implemented as designed specifically addressing: i. recruitment, ii. trial processes and procedures including completion of primary outcome measures, participant engagement with the program, and therapist intervention; and ii. program acceptability.
We hypothesise that the online FODMAP diet program will achieve a clinically meaningful change in total FODMAP intake and gastrointestinal IBS symptom improvement; and that the online FODMAP diet program will be feasible and acceptable to participants as indicated by meeting a priori identified benchmarks. We anticipate that the post treatment qualitative interviews will facilitate further refinement and optimisation of the online treatment prior to conducting the proposed randomised controlled trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jessica Biesiekierski

Address

Monash University BASE Facility 264 Ferntree Gully Rd, Notting Hill VIC 3168

Country

Australia

Phone

+61 0399024269

Fax

[email protected]

Contact person for public queries

Name

Jessica Biesiekierski

Address

Monash University BASE Facility 264 Ferntree Gully Rd, Notting Hill VIC 3168

Country

Australia

Phone

+61 0399024269

Fax

[email protected]

Contact person for scientific queries

Name

Jessica Biesiekierski

Address

Monash University BASE Facility 264 Ferntree Gully Rd, Notting Hill VIC 3168

Country

Australia

Phone

+61 0399024269

Fax

[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 of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

Only researchers who provide a methodologically sound proposal or case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

Only to achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
22146	Study protocol	[email protected]
22147	Informed consent form	[email protected]
22148	Ethical approval	[email protected]
22149	Statistical analysis plan	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically