Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001042538
Ethics application status
Approved
Date submitted
30/04/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Body and Brain in Irritable Bowel Syndrome (IBS) Study: Evaluating the effects of fructans on gastrointestinal symptoms in adults with mild to moderate IBS
Scientific title
The Body and Brain in IBS Study: Evaluating the effects of fructans on gastrointestinal symptoms in adults with mild to moderate IBS
Secondary ID [1] 311024 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 332141 0
Condition category
Condition code
Oral and Gastrointestinal 328864 328864 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
Participants will undertake 5 test phases, in random order, of approximately 7 days each in duration. Four of the test phases will begin with 3 consecutive days during which a test drink is consumed each day. These 3 days will be followed by a 4-day washout period during which no test drink is consumed. The same drink will be consumed on days 1, 2 and 3 of each test phase. Some test phases will include test drinks containing fructans, and some will not. The fifth test phase will involve the collection of identical outcome measures over 3-days however no test drink will be consumed. Test drinks will be made up by the participants who will add 100 ml of water to opaque bottles. These bottles will contain either 20 g of fructans powder (Orafti® P95 95% oligofructose) or an alternative non-fructan powder. The participant will prepare and consume the study drink within 3 minutes whilst online with a researcher.

This study will involve one in-person visit with a researcher at the research centre in Geelong, where baseline assessments will be completed. Throughout the study, participants will attend a total of 6 brief (approximately 10 minutes each) one-on-one Zoom videoconferencing visits with a blinded researcher. One of these visits will be held on day 1 of each of the five test phases. The sixth online visit (approximately 10 minutes) will be held to debrief participants upon completion of their final washout period.

For visits held on day 1 of each test phase, participants will attend fasted from midnight. Fasting will not be required on any other day of each test phase. Participants will collect a hydrogen breath sample, complete a series of questionnaires, and prepare and consume the test drink specified by the researcher whilst being guided and monitored online with the researcher. Participants will then be prompted by scheduled email/text notifications to collect two additional breath samples unsupervised (one each at 3 and 4 hours after consuming the test drink) and complete a brief series of questionnaires. These questionnaires will be completed again at the end of the day (before bed, approximately 15 hours after consuming the test drink).

On days 2 and 3 of each test phase, participants will be prompted by scheduled email/text notifications to complete a brief series of questionnaires and prepare and consume a test drink at the same time as on day 1. Participants will also be prompted to complete a brief series of questionnaires at 4 hours and at the end of the day.

Adherence to the intervention and completion of daily tasks recorded online will be monitored each test phase through check of completed participant questionnaires on REDCap. Participants will be instructed to keep their background diet unchanged and to maintain current treatment for their IBS during the intervention period.
Intervention code [1] 328451 0
Treatment: Other
Comparator / control treatment
A 7-day test phase in which no test drinks are consumed will serve as a comparator.
Control group
Active

Outcomes
Primary outcome [1] 336662 0
Peak and mean gut symptom response: 'overall symptoms'
Timepoint [1] 336662 0
Baseline and days 1-7 of each test phase
Secondary outcome [1] 434209 0
Peak and mean gut symptom response: bloating
Timepoint [1] 434209 0
Baseline and days 1-7 of each test phase
Secondary outcome [2] 434211 0
Stool consistency
Timepoint [2] 434211 0
Baseline and days 1-3 of each test phase
Secondary outcome [3] 434212 0
Global gut symptoms (adequate relief of IBS symptoms question)
Timepoint [3] 434212 0
Baseline and days 1-7 of each test phase
Secondary outcome [4] 435714 0
Stool frequency
Timepoint [4] 435714 0
Baseline and days 1-3 of each test phase
Secondary outcome [5] 435715 0
Peak and mean gut symptom response: nausea
Timepoint [5] 435715 0
Baseline and days 1-7 of each test phase
Secondary outcome [6] 435716 0
Peak and mean gut symptom response: flatulence
Timepoint [6] 435716 0
Baseline and days 1-7 of each test phase
Secondary outcome [7] 435717 0
Peak and mean gut symptom response: constipation
Timepoint [7] 435717 0
Baseline and days 1-7 of each test phase
Secondary outcome [8] 435718 0
Peak and mean gut symptom response: diarrhoea
Timepoint [8] 435718 0
Baseline and days 1-7 of each test phase
Secondary outcome [9] 435719 0
Peak and mean gut symptom response: urgency to pass stool
Timepoint [9] 435719 0
Baseline and days 1-7 of each test phase
Secondary outcome [10] 435720 0
Peak and mean gut symptom response: reflux
Timepoint [10] 435720 0
Baseline and days 1-7 of each test phase
Secondary outcome [11] 435721 0
Peak and mean gut symptom response: abdominal pain
Timepoint [11] 435721 0
Baseline and days 1-7 of each test phase.
Secondary outcome [12] 438284 0
Breath hydrogen
Timepoint [12] 438284 0
0 hours (immediately prior to consuming a test drink), 3 hours and 4 hours (after consuming the test drink) on day 1 of each test phase. Three breath samples will also be collected on day 1 of the test phase with no drink
Secondary outcome [13] 438285 0
Dietary Intake
Timepoint [13] 438285 0
Baseline, days 1-3 of each test phase, and day 7 of the first 4 test phases (i.e., the preparation day before each new test phase begins)

Eligibility
Key inclusion criteria
• Australian residents willing to drive to Geelong for one study visit
• Aged 18-65 years
• IBS diagnosed by GP or gastroenterologist and meeting the Rome IV criteria (screened at
baseline)
• Mild or moderate IBS symptoms (IBS-SSS score 75-300 pts)
• Familiar with fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) and fructans
• Access to internet on phone, tablet or computer
• Able to read and understand materials written in English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient-reported diagnosis of other gastrointestinal diseases (e.g. inflammatory bowel disease, acute diverticulitis coeliac disease)
• Patient-reported diagnosis of unstable mental illness (e.g. unstable schizophrenia, other psychotic disorders)
• Patient-reported diagnosis of current major medical conditions (e.g., cancer, dementia, type 1 and type 2 diabetes, cardiovascular disease, heart failure, chronic obstructive pulmonary disease).
• Patient-reported alcohol/substance abuse
• Eating disorder such as anorexia nervosa and bulimia nervosa (i.e. patient-reported or score equal to or greater than 3 on the ‘Sick, Control, One, Fat, Food’ (SCOFF) questionnaire)
• Pregnant, planning pregnancy or lactating
• Previous extensive GI surgery or stenotic disease e.g., major bowel resection, cholecystectomy (not appendicectomy or haemorrhoidectomy)
• Commenced prebiotics, probiotics or antibiotics in the past 4 weeks
• Current participation in another clinical trial
• Commencement or change in therapy for irritable bowel syndrome in the past month.

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)
Allocation will be concealed and involve contacting the holder of the allocation at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of test drink sequences will be balanced using a Latin Square design. The randomisation sequence will be generated by a statistician not involved in data collection or participant recruitment. The randomisation schedule and coding of sequence allocation will not be accessible to blinded researchers until after completion of primary data analysis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
6/04/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315286 0
Charities/Societies/Foundations
Name [1] 315286 0
Rome Foundation
Country [1] 315286 0
United States of America
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road Waurn Ponds VIC 3216 Australia
Country
Australia
Secondary sponsor category [1] 318523 0
None
Name [1] 318523 0
Address [1] 318523 0
Country [1] 318523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314209 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 314209 0
Ethics committee country [1] 314209 0
Australia
Date submitted for ethics approval [1] 314209 0
10/11/2023
Approval date [1] 314209 0
24/01/2024
Ethics approval number [1] 314209 0
2023-378

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

Contacts
Principal investigator
Name 130790 0
Dr Heidi Staudacher
Address 130790 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 130790 0
Australia
Phone 130790 0
+61 3 522 78891
Fax 130790 0
Email 130790 0
[email protected]
Contact person for public queries
Name 130791 0
Leena Putkonen
Address 130791 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 130791 0
Australia
Phone 130791 0
+61 404559164
Fax 130791 0
Email 130791 0
[email protected]
Contact person for scientific queries
Name 130792 0
Heidi Staudacher
Address 130792 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 130792 0
Australia
Phone 130792 0
+61 3 522 78891
Fax 130792 0
Email 130792 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?

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.