Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000340538
Ethics application status
Approved
Date submitted
19/02/2024
Date registered
26/03/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary treatment for irritable bowel syndrome: a pathway to disordered eating? A pilot study
Scientific title
Dietary treatment for irritable bowel syndrome in adults: a pathway to disordered eating? A pilot study
Secondary ID [1] 311563 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 332928 0
Disordered eating 332929 0
Condition category
Condition code
Oral and Gastrointestinal 329645 329645 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 329646 329646 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary intervention: The dietary intervention is designed to mimic exactly what is used in clinical practice when instituting the low FODMAP (fermentable oligo- di- mono-saccharides and polyols) diet. Participants will have 2 visits (6 weeks apart) with the dietitian, each up to 1 hour in length either face-to-face or via videoconference.

As such at Week-0, participants will be instructed by an experienced dietitian to follow a low FODMAP diet for 6-weeks. The low FODMAP diet involves reducing intake of specific foods high in FODMAPs such as wheat, rye, onion, garlic, honey, apples and pears. In replacement of these foods, low FODMAP options will be encouraged such as gluten free bread, rice, carrots, zucchini, maple syrup, oranges and kiwifruit.

At Week-6, participants will be instructed to reintroduce FODMAPs to determine their level of tolerance. Using strategic re-challenges, participants will re-introduce 1 food at a time to monitor their symptom response, if symptoms do not occur, it is assumed they can tolerate that FODMAP and re-introduce it back into the diet. Once the participant has completed the re-challenges (usually ~6 weeks later), they will be asked to return (via email) their re-challenge record to the researchers. Should they have any questions the participants can contact the study dietitian via email.

To assist with compliance and be consistent with clinical practice, Dr Caroline Tuck’s email address will be provided to participants should they have any specific questions regarding the dietary modifications between visits. Participants will complete a 3-day food diary at week 0 and week 6 to monitor adherence to the diet.

Each visit will be 60 minutes, and standardized language and written information will be provided. Additionally, to enhance clinical outcomes participants will be provided with the Monash University Low FODMAP diet Smartphone App. A code will be generated for participants to access and download the app on their phone for free. Participants can use the app at their own discretion. The app provides details on the FODMAP rating (i.e. low, moderate or high in FODMAPs) of a large range of foods and also provides recipes. No monitoring of app usage will occur in the study, it will be provided as a supportive/educational tool.
Intervention code [1] 328016 0
Treatment: Other
Intervention code [2] 328137 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337432 0
Primary aim: assess the number of participants classified as meeting disordered eating criteria based on a provisional psychologist’s clinical assessment following the intervention.
Timepoint [1] 337432 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [1] 431829 0
Secondary aim: compare the reliability of a screening questionnaire (EAT26 score of 20 or greater indicating disordered eating), compared to the provisional psychologist’s clinical assessment.
Timepoint [1] 431829 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [2] 431830 0
Tertiary aim: exploratory analysis will be employed to assess ways to predict those most likely to develop disordered eating via assessment of eating motivations.
Timepoint [2] 431830 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [3] 432464 0
Tertiary aim: Level of completion of the Phase 2 re-challenge phase will be compared in those with and without disordered eating as identified following the intervention (6-week timepoint).
Timepoint [3] 432464 0
At ~12 weeks from the start of the FODMAP diet when the re-challenge information is returned to the researchers.
Secondary outcome [4] 432465 0
Tertiary aim: exploratory analysis will be employed to assess ways to predict those most likely to develop disordered eating via assessment of visceral sensitivity.
Timepoint [4] 432465 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [5] 432466 0
Tertiary aim: exploratory analysis will be employed to assess ways to predict those most likely to develop disordered eating via assessment of depression, anxiety, and stress.
Timepoint [5] 432466 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [6] 432467 0
Tertiary aim: exploratory analysis will be employed to assess ways to predict those most likely to develop disordered eating via assessment of quality of life.
Timepoint [6] 432467 0
At 6 weeks from the start of the FODMAP diet
Secondary outcome [7] 436608 0
Explore disordered eating screening scores at 3-month timepoint (via EAT-26)
Timepoint [7] 436608 0
Secondary outcome [8] 436609 0
Explore disordered eating screening scores at 3-month timepoint (via EAT-26)
Timepoint [8] 436609 0
3 months from the start of the FODMAP diet
Secondary outcome [9] 436610 0
Validated disordered eating scales (SCOFF)
Timepoint [9] 436610 0
3 months from the start of the FODMAP diet
Secondary outcome [10] 436611 0
Validated disordered eating scales (SCOFF)
Timepoint [10] 436611 0
3 months from the start of the FODMAP diet
Secondary outcome [11] 436612 0
Validated disordered eating scales (NIAS)
Timepoint [11] 436612 0
3 months from the start of the FODMAP diet
Secondary outcome [12] 436613 0
Validated disordered eating scales (NIAS)
Timepoint [12] 436613 0
3 months from the start of the FODMAP diet
Secondary outcome [13] 436614 0
Explore disordered eating screening scores at 3-month timepoint
Validated disordered eating scales (EHQ)
Timepoint [13] 436614 0
3 months from the start of the FODMAP diet
Secondary outcome [14] 436615 0
Explore disordered eating screening scores at 3-month timepoint
Validated disordered eating scales (EHQ)
Timepoint [14] 436615 0
3 months from the start of the FODMAP diet

Eligibility
Key inclusion criteria
• Males and females aged 18 years and older
• Meet the Rome IV criteria for IBS (all subtypes)
• Not have previously undertaken dietary interventions
• Stable medications and psychological therapies for their gastrointestinal symptoms for at least 8-weeks.
• Proficient in English
• Based on clinical assessment by the provisional psychologist, not meet the DIAMOND Criteria for disordered eating at baseline.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Mild IBS symptoms (score <75 on the IBS-SSS)
• Known history of other gastrointestinal conditions or an eating disorder
• Taking psychotropic medications
• Taken antibiotics or probiotics in the past 4 weeks.
• Meet disordered eating criteria at baseline as per clinical assessment.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be controlled for sex and BMI (known predictors of disordered eating). McNemar’s test will detect if the proportion of patients with disordered eating at the end of intervention is different compared to baseline. Secondary endpoints will assess the reliability of the screening questionnaires (validated versions and GI-modified versions) to the clinical assessment. Further exploratory analysis will assess those with or without disordered eating at the end of the study regarding eating motivations, visceral sensitivity, depression, anxiety, stress, and quality of life to identify any ways to predict those most likely to develop disordered eating.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/05/2024
Actual
28/05/2024
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
27
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315862 0
University
Name [1] 315862 0
Swinburne University of Technology
Country [1] 315862 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 317998 0
None
Name [1] 317998 0
Address [1] 317998 0
Country [1] 317998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314712 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 314712 0
Ethics committee country [1] 314712 0
Australia
Date submitted for ethics approval [1] 314712 0
31/01/2024
Approval date [1] 314712 0
14/03/2024
Ethics approval number [1] 314712 0

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

Contacts
Principal investigator
Name 132486 0
Dr Caroline Tuck
Address 132486 0
Swinburne University, John Street, Hawthorn VIC 3122
Country 132486 0
Australia
Phone 132486 0
+61 03 9214 4340
Fax 132486 0
Email 132486 0
[email protected]
Contact person for public queries
Name 132487 0
Caroline Tuck
Address 132487 0
Swinburne University, John Street, Hawthorn VIC 3122
Country 132487 0
Australia
Phone 132487 0
+61 03 9214 4340
Fax 132487 0
Email 132487 0
[email protected]
Contact person for scientific queries
Name 132488 0
Caroline Tuck
Address 132488 0
Swinburne University, John Street, Hawthorn VIC 3122
Country 132488 0
Australia
Phone 132488 0
+61 03 9214 4340
Fax 132488 0
Email 132488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21685Informed consent form  [email protected]



Results publications and other study-related documents

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