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Trial registered on ANZCTR
Registration number
ACTRN12617000465358
Ethics application status
Approved
Date submitted
28/03/2017
Date registered
30/03/2017
Date last updated
2/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of a low fementable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet on intestinal transit, the intestinal microbiome and metabolome in adults with irritable bowel syndrome..
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Scientific title
An intervention study investigating the effect of a low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet on gastrointestinal transit time and diversity of the microbiome and metabolome in adults with irritable bowel syndrome.
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Secondary ID [1]
291554
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None
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Universal Trial Number (UTN)
U1111-1186-5261
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Trial acronym
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Linked study record
ACTRN12616001162404
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Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome
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Condition category
Condition code
Oral and Gastrointestinal
302164
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
10 participants with diarrhea predominant irritable bowel syndrome [IBS(D)] or [IBS(M)] from study ACTRN12616001162404 who do not have small intestinal bacteria overgrowth will be asked to participate.
They will be educated on a low FODMAP diet which is low in fermentable short chain carbohydrates. Foods which participants need to reduce include but are not limited to wheat products, apples, onion and garlic. They will be shown the Monash University low FODMAP app, which includes a traffic light system on which foods are suitable and a video clip on how the diet works as well as recipes. They will be given additional recipes to use that are low FODMAP. They will be asked to follow this diet strictly. Dietary education will be given by a New Zealand registered dietitian with 10 years experience who is familiar with a low FODMAP diet. These education session with be conducted individually and last for 45 minutes.
Timeline for the diet and investigations:
Week 1: participants follow usual diet
Week 2: participants provide a second urine and stool sample (the first fecal and urine samples were given in the earlier trial ACTRN12616001162404) after which they consume a smart pill while on their usual diet
Week 3-6: participants follow a strict low FODMAP diet (receiving 45 minutes dietary education at the beginning of week 3)
Week 7: participants provide a third urine and stool sample after which they consume a smart pill. During this week they remain on a strict low FODMAP diet
Week 8-12: Participants will be given 30 minutes education on how to reintroduce FODMAP containing foods to tolerance
Adherence to the diet will be measured by 7 telephone diet recalls conducted by two nutrition students (done in weeks 1-7). They will be checking for evidence of high FODMAP food intake and reporting on this.
Each participant will act as their own control therefore 10 participants should be sufficient for this part of the study.
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Intervention code [1]
297618
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Lifestyle
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Comparator / control treatment
Each participant will serve as their own control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Diversity of the microbiome
DNA will be extracted from the fecal samples and sequenced. The Shannon’s index of diversity will be used to compare diversity of the samples. The composition of the samples prior to commencing a low FODMAP diet and after following the diet will be compared using techniques designed for the analysis of compositional data under the guidance of Professor Greg Gloor who has extensive experience in analyzing microbiome data sets.
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Assessment method [1]
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Timepoint [1]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Primary outcome [2]
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Intestinal transit time using the smart pill
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Assessment method [2]
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Timepoint [2]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Secondary outcome [1]
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pH (using the smart pill)
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Assessment method [1]
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Timepoint [1]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Secondary outcome [2]
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Change in metabolome
LC/MS and GC/MS will be used to detect the small molecules present in the urine. Data will then be analyzed using techniques designed for the analysis of compositional data
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Assessment method [2]
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Timepoint [2]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Secondary outcome [3]
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Change in IBS symptom severity scoring system (IBS SSS)
This is the clinical outcome measure, the subscales within this will also be analyzed individually
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Assessment method [3]
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Timepoint [3]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Secondary outcome [4]
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Change in IBS quality of life (IBS QoL)
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Assessment method [4]
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Timepoint [4]
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Before commencing a low FODMAP diet and after 4 weeks on the diet
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Eligibility
Key inclusion criteria
*Previously enrolled in study ACTRN12616001162404
*IBS (D) or IBS (M) according to Rome III criteria
*Fluent in English
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Organic gastrointestinal disease
* Diabetes
* Serious neurological or respiratory conditions
* Pancreatitis
* Small intestinal bacteria overgrowth
* Antibiotics within the last six week
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Statistical analysis will be performed using Stat (Version 13.1 CITY, TX, USA). Data will be presented as mean and standard deviation unless otherwise stated. Students’ t tests will be used to compare baseline continuous data and Fisher’s exact test for categorical data. Paired students’ t test will be used to compare differences in continuous variables before commencing the low FODMAP diet and after 4 weeks on the diet. A p value of =0.05 will be deemed statistically significant.
The microbiome data will be analysed using the approaches of compositional data (CoDa) analysis that we have pioneered in the fields of microbiome and RNA-seq research, and all approaches used below follow a CoDa paradigm. CoDa analysis methods ensure that the analysis is robust to which OTU sequences are included, the order of the sequences, sequencing depth and random sampling. In essence, the CoDa approach examines the ratios between the OTU abundances, similar to what would be done with a quantitative PCR approach with an internal standard. The essential steps here are to convert the data into logarithms of ratios, and this step opens up the entire multivariate statistical toolkit.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
3/04/2017
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Actual
9/08/2017
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Date of last participant enrolment
Anticipated
30/06/2017
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Actual
13/09/2017
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Date of last data collection
Anticipated
1/09/2017
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Actual
12/10/2017
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Sample size
Target
10
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Accrual to date
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Final
5
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago
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Address [1]
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Dunedin School of Medicine
First Floor, Dunedin Hospital
Great King Street
Dunedin 9016
New Zealand
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Michael Schultz
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Address
Dunedin School of Medicine
First Floor, Dunedin Hospital
Great King Street
Dunedin 9016
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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Lawson Health Research Institute, London, Ontario
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Address [1]
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268 Grosvenor St,
London,
ON N6A 4V2
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Country [1]
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Canada
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Western University Health Science Research Ethics Board
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Ethics committee address [1]
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Western University Research Support Services Building Rm 5150 London Ontario N6G 1G9
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Ethics committee country [1]
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Canada
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Date submitted for ethics approval [1]
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07/12/2016
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Approval date [1]
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08/02/2017
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Ethics approval number [1]
297301
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107228
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Summary
Brief summary
The low FODMAP diet has been shown to be effective for ~70% of IBS patients. However, concerns have been raised that as it is lower in oligosaccharides it may reduce the variety of bacteria in the bowel (microbial diversity). Microbial diversity is associated with health. Two recently published studies have suggested that for people with IBS(D) following a low FODMAP diet may not have a reduction in microbial diversity. One other factor associated with increased diversity is longer transit time through the gastrointestinal tract. We are using a wireless motility capsule or a “smartpill” to measure intestinal transit time, pH, temperature and pressure when participants are following a normal diet and when they are following a low FODMAP diet. The purpose of this study is to see if a low FODMAP diet slows down transit through the intestines and if it has an effect on pH inside the gastrointestinal tract. 10 people with IBS who enrolled for ACTRN12616001162404 but did not have SIBO will be asked to participate in this study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Michael Schultz
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Address
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Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand
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Country
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New Zealand
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Phone
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+64 3 474 0999
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ruth Harvie
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Address
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c/- The Canadian centre for the human microbiome and probiotics
Lawson Research Institute
268 Grosvenor St
London
Ontario
N6A 4V2
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Country
73635
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Canada
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Phone
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+1 519 317 2384
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Michael Schultz
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Address
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Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand
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Country
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New Zealand
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Phone
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+64 3 474 0999
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Fax
73636
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Email
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[email protected]
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No information has been provided regarding IPD availability
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.
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