Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000353695
Ethics application status
Approved
Date submitted
10/03/2023
Date registered
5/04/2023
Date last updated
5/04/2023
Date data sharing statement initially provided
5/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial of faecal microbiota transplantation versus placebo in patients who are non -responders to the low FODMAP diet.
Query!
Scientific title
: A randomised controlled trial of the effect of faecal microbiota transplantation versus placebo on symptom severity for low FODMAP diet non-responder IBS patients
Query!
Secondary ID [1]
309176
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome
329310
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
326255
326255
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
All participants will be administered the low FODMAP diet prior to the faecal microbiota transplantation. If there is no improvement in IBS-SSS score post low FODMAP then participants will enter randomisation into FMT vs placebo.
Faecal microbiota transplantation
- this will be administered via a single 60ml rectal retention enema in one clinic visit
- one donor will be used for each participant
- adherence to FMT will be 100% as it is administered by the study investigator and the subject will be monitored for 30 minutes
low FODMAP diet
- will be administered by a qualified dietician
- adherence will be assessed through the use of a food diary with weekly reviews by the dietician over 3 weeks.
Query!
Intervention code [1]
325623
0
Treatment: Other
Query!
Comparator / control treatment
Placebo controlled - glycerol and saline (4:1 ratio), food coloring (3ml on 1L) and 5g fibre (2g apple fibre, 3g inulin) on 1 litre solution
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
334129
0
Irritable Bowel Syndrome Symptom Score
Query!
Assessment method [1]
334129
0
Query!
Timepoint [1]
334129
0
1 month post faecal microbiota transplantation
Query!
Secondary outcome [1]
419437
0
IBS-Quality of Life questionnaire
Query!
Assessment method [1]
419437
0
Query!
Timepoint [1]
419437
0
1 - month, 3-month, 6-month and 12-month post transplant
Query!
Secondary outcome [2]
419609
0
Microbiome dysbiosis index via 16S RNA analysis on stool sample
Query!
Assessment method [2]
419609
0
Query!
Timepoint [2]
419609
0
1 - month, 3-month, 6-month and 12-month post transplant
Query!
Secondary outcome [3]
419610
0
Cognition function via University of Cambridge, the Cambridge Neuropsychological Test Automated Battery (CANTAB) questionnaire
Query!
Assessment method [3]
419610
0
Query!
Timepoint [3]
419610
0
1 - month, 3-month, 6-month and 12-month post transplant
Query!
Secondary outcome [4]
420178
0
Microbiome analysis via 16sRNA will be tested on stool sample
Query!
Assessment method [4]
420178
0
Query!
Timepoint [4]
420178
0
1 - month, 3-month, 6-month and 12-month post transplant
Query!
Eligibility
Key inclusion criteria
1. Aged 18 years old or over
2. Diagnosed with irritable bowel syndrome as per ROME IV criteria
3. An outpatient
4. Lack of symptomatic improvement with the low FODMAP diet
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Presence of systemic disease
2. Pregnant, planning pregnancy or lactating.
3. Having undergone any abdominal surgery, with the exception
of appendectomy, cholecystectomy, caesarean section and hysterectomy.
4. Severe psychiatric disorder, or alcohol or drug abuse.
5. Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry
6. Use of IBS medication within the previous 3 months, with the exception of polyethylene glycol and loperamide.
7. Active gastroenteritis
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Simple 1:1 randomisation , central randomisation by phone/fax/computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of sequence generation will be generated from a computer software program that generates the random sequence
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
6/04/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
313374
0
Self funded/Unfunded
Query!
Name [1]
313374
0
Query!
Address [1]
313374
0
Query!
Country [1]
313374
0
Query!
Primary sponsor type
Individual
Query!
Name
Vincent Ho
Query!
Address
Western Sydney University ·
Narellan Road, Campbelltown New South Wales 2560
Query!
Country
Australia
Query!
Secondary sponsor category [1]
315139
0
None
Query!
Name [1]
315139
0
Query!
Address [1]
315139
0
Query!
Country [1]
315139
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
312591
0
Western Sydney University
Query!
Ethics committee address [1]
312591
0
Western Sydney University
Narellan Road, Campbelltown New South Wales 2560
Query!
Ethics committee country [1]
312591
0
Australia
Query!
Date submitted for ethics approval [1]
312591
0
Query!
Approval date [1]
312591
0
05/04/2022
Query!
Ethics approval number [1]
312591
0
Query!
Summary
Brief summary
On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms.
This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet.
Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
125210
0
Dr Vincent Ho
Query!
Address
125210
0
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
School of Medicine, Western Sydney University
Query!
Country
125210
0
Australia
Query!
Phone
125210
0
+61 02 4628 4905
Query!
Fax
125210
0
Query!
Email
125210
0
[email protected]
Query!
Contact person for public queries
Name
125211
0
Dr Vincent Ho
Query!
Address
125211
0
Dr Vincent Ho
School of Medicine, Western Sydney University
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Query!
Country
125211
0
Australia
Query!
Phone
125211
0
+61 02 4628 4905
Query!
Fax
125211
0
Query!
Email
125211
0
[email protected]
Query!
Contact person for scientific queries
Name
125212
0
Dr Vincent Ho
Query!
Address
125212
0
Dr Vincent Ho
School of Medicine, Western Sydney University
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Query!
Country
125212
0
Australia
Query!
Phone
125212
0
+61 02 4628 4905
Query!
Fax
125212
0
Query!
Email
125212
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF