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Trial registered on ANZCTR


Registration number
ACTRN12624000185561
Ethics application status
Approved
Date submitted
21/12/2023
Date registered
27/02/2024
Date last updated
27/02/2024
Date data sharing statement initially provided
27/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the tolerability of nutritive and non-nutritive sweeteners in people with irritable bowel syndrome
Scientific title
Exploring the tolerability of nutritive and non-nutritive sweeteners in people with irritable bowel syndrome
Secondary ID [1] 311234 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 332441 0
Condition category
Condition code
Oral and Gastrointestinal 329132 329132 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet.


The study will following the following order - baseline (day 1), test period 1 (Days 2-3), washout (days 4-8), test period 2 (days 9-10), washout (days 11-15), test period 3 (days 16-17), washout (18-22), test period 4 (days 23-24), washout (days 25-29), test period 5 (days 30-31).

In baseline, participants will consume their habitual, low FODMAP diet. They will also to complete a food diary, symptom questionnaire, and collect hourly breath samples from 8am to 8pm into breath collection bags.

For the 2 days of each test period, participants will consume a supplied, low FODMAP diet provided by our certified, specialty pre-made meals supplier, WeFeedYou. During each test period, they will also consume 2 test foods e.g. breakfast (smoothie), morning tea (protein ball/bar/muffin). These tests foods will be masked with 1 of the 5 test sugars (erythritol, monk fruit extract, stevia, allulose or sucrose).

Each test food will contain 1 sugar in the following amounts:
100% Sucrose - 30g
100%Erythritol - 49.4g
100%Monk fruit extract - 3.4g
100% Stevia - 0.7g
100% Allulose - 53.9g

Participants will be randomised `and blinded to the order in which they are exposed to the 5 sweeteners during the test periods. Throughout each test period, participants will also complete the food diary (to monitor compliance) and daily symptom questionnaire (to monitor tolerance). On the 2nd day of each test period, participants will also collect hourly breath samples between 8am and 8pm into breath collection bags. These breath samples will be used to assess breath hydrogen response which is a marker of fermentation in the large intestine.

In each 5 day washout period, participants will return to their habitual, low FODMAP diet.
Intervention code [1] 327690 0
Lifestyle
Comparator / control treatment
Sucrose
Control group
Active

Outcomes
Primary outcome [1] 336966 0
Gastrointestinal symptoms (composite of abdominal pain, bloating/distension, satisfaction with bowel function, interference of bowel symptoms on daily life). This will be assessed using the IBS-Symptom severity score (IBS-SSS).

The IBS-SSS is a self-report questionnaire designed to assess the severity of symptoms in individuals with irritable bowel syndrome (IBS). The IBS-SSS consists of five items that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life.

The primary outcome will be the total score (0 to 500 points).
Timepoint [1] 336966 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [1] 430275 0
Abdominal symptoms overall
Timepoint [1] 430275 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [2] 431015 0
Abdominal pain / bloating
Timepoint [2] 431015 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [3] 431016 0
Abdominal bloating
Timepoint [3] 431016 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [4] 431017 0
Wind
Timepoint [4] 431017 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [5] 431018 0
Satisfaction with stool consistency
Timepoint [5] 431018 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [6] 431019 0
Tiredness and lethargy
Timepoint [6] 431019 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)
Secondary outcome [7] 431020 0
Nausea
Timepoint [7] 431020 0
Day 1 baseline
Day 3 intervention (test sugar 1)
Day 10 intervention (test sugar 2)
Day 17 intervention (test sugar 3)
Day 24 intervention (test sugar 4)
Day 31 intervention (test sugar 5)

Eligibility
Key inclusion criteria
Irritable bowel syndrome and symptoms well controlled on a low FODMAP diet.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age under 18 - need to be of adult consent age
- Recent gastrointestinal surgery (within last 3 months) - this would have an effect on gut symptoms
- Coeliac disease and/or other gastrointestinal disease, food allergy/intolerances, malnutrition, other dietary restrictions (e.g. vegan or vegetarian) - these conditions all require special diets and the supplied dietary intervention would potentially be contraindicated
- Pregnancy or breastfeeding - this could potentially affects gut symptoms
- Active psychological illness including eating disorders - this could affect compliance with the dietary intervention
-People living outside of metro-Melbourne

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 randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
15/07/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315467 0
Commercial sector/Industry
Name [1] 315467 0
Modify Health
Country [1] 315467 0
United States of America
Funding source category [2] 315490 0
University
Name [2] 315490 0
Monash University
Country [2] 315490 0
Australia
Primary sponsor type
University
Name
Monash University
Address
99 commercial Rd, Melbourne 3004
Country
Australia
Secondary sponsor category [1] 317565 0
None
Name [1] 317565 0
Address [1] 317565 0
Country [1] 317565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314376 0
Monas University Human Research Ethics Committee
Ethics committee address [1] 314376 0
Ethics committee country [1] 314376 0
Australia
Date submitted for ethics approval [1] 314376 0
16/06/2023
Approval date [1] 314376 0
13/09/2023
Ethics approval number [1] 314376 0
38778

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

Contacts
Principal investigator
Name 131358 0
Dr Jane Varney
Address 131358 0
Monash University, Department of Gastroenterology, Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 131358 0
Australia
Phone 131358 0
+61 412944848
Fax 131358 0
Email 131358 0
jane.varney@monash.edu
Contact person for public queries
Name 131359 0
Jane Varney
Address 131359 0
Monash University, Department of Gastroenterology, Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 131359 0
Australia
Phone 131359 0
+61 412944848
Fax 131359 0
Email 131359 0
jane.varney@monash.edu
Contact person for scientific queries
Name 131360 0
Jane Varney
Address 131360 0
Monash University, Department of Gastroenterology, Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 131360 0
Australia
Phone 131360 0
+61 412944848
Fax 131360 0
Email 131360 0
jane.varney@monash.edu

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?

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
No additional documents have been identified.