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Trial registered on ANZCTR


Registration number
ACTRN12611000556943
Ethics application status
Approved
Date submitted
31/05/2011
Date registered
1/06/2011
Date last updated
28/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Food for Irritable Bowel Syndrome. The FIBS study
Scientific title
An investigation into the effect of FODMAPS(Fermentable Oligo-, di- and mono saccharides and polyols) dietary education in conjunction with hydrogen breath testing on symptom severity and quality of life for patients with Irritable Bowel Syndrome.
Secondary ID [1] 262279 0
Nil
Universal Trial Number (UTN)
Trial acronym
Food for Irritable Bowel Syndrome (FIBS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 267981 0
Condition category
Condition code
Oral and Gastrointestinal 268113 268113 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 in the treatment group will receive four dietary education sessions (one hour for the first one, then 3x30 minutes for follow up) with the dietitian during the three month period.
The dietary session will be individual with the dietitian explaining the mechanism for a low FODMAPS diet, assessing the participants diets and giving guidance on adapting the participants diet
Intervention code [1] 266671 0
Lifestyle
Comparator / control treatment
Participants will be randomised to immediate treatment or to become a waiting list control patient. The waiting list control group will be seen 3 months after filling out the initial questionnaires
Control group
Active

Outcomes
Primary outcome [1] 266862 0
Difference in score on the IBS Symptom Severity Scoring System
Timepoint [1] 266862 0
baseline, 3 months and 6 months
Secondary outcome [1] 276517 0
Difference in score on the IBS Quality of Life
Timepoint [1] 276517 0
baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
Irritable Bowel Syndrome meeting the ROME III criteria
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
currently seeing a dietitian, having gastrointestinal surgery, not speaking English

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)
Patients will be identified through Gastroenterology clinics and if required GP practices. The initial approach will be made by the doctor. If participants are keen to participate the research dietitian will then contact them to explain the trial and provide them with the participant information sheet and consent form. Once written consent has been obtained then the patients will be screened using hydrogen breath tests. Baseline questionnaires will be collected and patients will be randomly assigned to treatment or waiting list control. The dietitian will be informed by the person holding the randomisation schedule of the treatment allocation (allocation concealment).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An algorithm will be devised based on age, gender and initial symptom severity. Based on this algorithm a computer will randomly assign patients to either immediate treatment or a three month delay. The randomisation schedule will be held by a person unrelated to the trial who will inform the dietitian which group participants have been assigned once all baseline measures have been completed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3605 0
New Zealand
State/province [1] 3605 0
Otago

Funding & Sponsors
Funding source category [1] 267163 0
University
Name [1] 267163 0
Dunedin School of Medicine and Southern District Health Board NZ through a research award
Address [1] 267163 0
University of Otago
Department of Medicine
PO Box 913
Dunedin 9054
Country [1] 267163 0
New Zealand
Funding source category [2] 294379 0
Charities/Societies/Foundations
Name [2] 294379 0
Neige Todhunter Award; Dietitian's NZ
Address [2] 294379 0
23-29 Broderick Road, Johnsonville, Wellington 6140,
Country [2] 294379 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
Department of Medicine
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 266241 0
None
Name [1] 266241 0
Address [1] 266241 0
Country [1] 266241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269153 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 269153 0
Upper South A Regional Ethics Committee
c/- Ministry of Health
Montgomery Watson Building
6 Hazeldean Road
Christchurch 8024
Ethics committee country [1] 269153 0
New Zealand
Date submitted for ethics approval [1] 269153 0
Approval date [1] 269153 0
23/05/2011
Ethics approval number [1] 269153 0
URA/11/05/015

Summary
Brief summary
This study is looking at a new style of dietary treatment for Irritable Bowel Syndrome (IBS). The aim of the study is to see how effective the treatment is long-term and to identify reasons why patients may not follow the treatment even if it is beneficial.
It is known that people with IBS get increased wind, bloating and abdominal pain together with an altered bowel habit when they eat some foods which most people are able to digest without problems. Patients who are likely to respond to this treatment will be referred to the dietitian who will provide education on how to limit those foods in the diet. Hydrogen breath tests can be used to identify people most likely to malabsorb these foods.
Participants will be asked to fill out three different questionnaires on three separate occasions (baseline, 3 and 6 months) which provide information on how IBS affects their life and what they eat. Analysis will provide data about the long-term effect of the diet however, it is expected that patients might not comply long-term to this diet because the foods recommended in this treatment are more expensive than a usual diet open ended questions will be asked about barriers to making the recommended dietary changes and an estimation of the increased cost will be calculated.
Trial website
Trial related presentations / publications
Harvie RM, Chisholm AW, Bisanz JE, Burton JP, Herbison P, Schultz K, Schultz M. Long-term irritable bowel syndrome symptom control with reintroduction of selected FODMAPs. World J Gastroenterol 2017; 23(25): 4632-4643.

Demultiplexed sequence and associated metadata was deposited in the NCBI short read archive with BioProject accession PRJNA392762.
Public notes

Contacts
Principal investigator
Name 32676 0
A/Prof Michael Schultz
Address 32676 0
C/- Dunedin School of Medicine
Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand
Country 32676 0
New Zealand
Phone 32676 0
64 3 474 0999
Fax 32676 0
Email 32676 0
michael.schultz@otago.ac.nz
Contact person for public queries
Name 15923 0
Ms Ruth Harvie
Address 15923 0
PhD researcher
Canadian Centre for the human microbiome and probiotics
268 Grosvenor St
London
Ontario
Canada
ON N6A 4V2
Country 15923 0
Canada
Phone 15923 0
+1 519 317 2384
Fax 15923 0
Email 15923 0
ruth.harvie@postgrad.otago.ac.nz
Contact person for scientific queries
Name 6851 0
A/Prof Dr Michael Schultz
Address 6851 0
University of Otago
Department of Medicine
PO Box 913
Dunedin 9054
Country 6851 0
New Zealand
Phone 6851 0
+64 3 474 0999
Fax 6851 0
+64 3 474 7724
Email 6851 0
michael.schultz@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary