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Trial registered on ANZCTR


Registration number
ACTRN12612001185853
Ethics application status
Approved
Date submitted
29/10/2012
Date registered
9/11/2012
Date last updated
9/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of dietary Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) in the genesis of symptoms in patients with irritable bowel syndrome and Crohn's disease
Scientific title
The role of dietary Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) in the genesis of symptoms in patients with irritable bowel syndrome and Crohn's disease
Secondary ID [1] 281456 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 287718 0
Crohn's disease 287719 0
Condition category
Condition code
Oral and Gastrointestinal 288054 288054 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 288056 288056 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary intervention of a low FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) diet. The low FODMAP diet is a diet with very low amounts of these fermentable sugars and requires the restriction of foods such as milk, apples, pears, watermelon, wheat, rye, onion and garlic. Participants were provided with low FODMAP meals (3 meals and 3 snacks daily) but asked to control the meal/snack portions according to their appetite. The average daily FODMAP content on the low FODMAP diet was less than 2g compared to the average typical Australian diet of 20g. Participants are required to follow a low FODMAP and typical Australian diet for three weeks each and all food is provided. This trial is a crossover study which was already provided in a later field of this trial record. All food will be provided on three weeks of the low FODMAP and three weeks of the typical Australian diet. All participants will have a minimum of three-week washout period (returning to their usual diet) before crossing over to the alternate diet
Intervention code [1] 285959 0
Treatment: Other
Comparator / control treatment
A typical Australian diet will be used to assess changes in symptoms and faecal characteristics compared to the low FODMAP diet. The typical Australian diet will include commonly eaten foods and meals (e.g. apples and chicken risotto) and will include FODMAP at each meal and snack. Participants will remain on the typical Australian diet for three weeks and all food will be provided.
Control group
Active

Outcomes
Primary outcome [1] 288261 0
Overall gastrointestinal symptoms on a low versus typical Australian diet using a visual analogue scale (VAS) which participants will complete daily. Participants will indicate symptom severity by a marking on a 100mm line. 0 indicates no symptoms and 100mm worst symptoms ever experienced.
Timepoint [1] 288261 0
On a daily basis over the three weeks of the intervention.
Secondary outcome [1] 299707 0
Specific gastrointestinal symptoms of abdominal pain, bloating, passage of wind and dissatisfaction of stool consistency on a low versus typical Australian diet by using the VAS as described for the primary outcome.
Timepoint [1] 299707 0
On a daily basis over the three weeks of the intervention.
Secondary outcome [2] 299708 0
Faecal biomarkers of whole gut transit time, pH, short-chain fatty acids and microbiota on a low versus typical Australian diet. Transit time capsules will be ingested on day 17 of each diet intervention and a five-day faecal sample collected and immediately stored in provided portable freezers. Stool will be x-rayed to determine time that transit markers were passed and pH, short-chain fatty acids and microbiota will be assessed at Commonwealth Scientific and Industrial Research Organisation (CSIRO) using their current methods of analysis.
Timepoint [2] 299708 0
After three weeks of intervention
Secondary outcome [3] 299709 0
Intestinal permeability on a low versus typical Australian diet. This will be assessed on the last day of each diet intervention by a five-hour urine collection after the ingestion of the sugars lactulose and rhamnose. The ratio of lactulose and rhamnose in the urine indicates the amount passed across the small intestine.
Timepoint [3] 299709 0
After three weeks of intervention

Eligibility
Key inclusion criteria
IBS: FODMAP-naive, IBS diagnosed by Rome III criteria
Crohn's disease: inactive disease
Healthy controls: no reported gastrointestinal symptoms
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Crohn's disease: prior bowel resection

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)
Participants will be recruited from Eastern Health Functional Gut Clinic, Monash University Breath Testing Centre, advertisement through local newspapers and word of mouth. People interested in participating in the study will be assessed by a gastroenterologist to determine eligibility. If eligible, each participant will be randomised by central randomisation by computer. The participants will be blinded to the diets which are referred to as 'pink diet' and 'yellow diet' instead of typical Australian and low FODMAP diets.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the first diet that they receive using a computer-generated block randomisation programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All food will be provided on three weeks of the low FODMAP and three weeks of the typical Australian diet. All participants will have a minimum of three-week washout period (returning to their usual diet) before crossing over to the alternate diet.
Phase
Not Applicable
Type of endpoint(s)
Safety/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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286227 0
Government body
Name [1] 286227 0
National Health and Medical Research Council
Address [1] 286227 0
Level 1/16 Marcus Clarke St
Canberra ACT 2601
Country [1] 286227 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
Level 1/16 Marcus Clarke St
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 285035 0
Charities/Societies/Foundations
Name [1] 285035 0
Les and Eva Erdi Foundation
Address [1] 285035 0
195 Swanston St
Melbourne VIC 3000
Country [1] 285035 0
Australia
Other collaborator category [1] 277142 0
Government body
Name [1] 277142 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address [1] 277142 0
Kintore Ave
Adelaide SA 5000
Country [1] 277142 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288295 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 288295 0
Level 2/5 Arnold St
Box Hill VIC 3128
Ethics committee country [1] 288295 0
Australia
Date submitted for ethics approval [1] 288295 0
Approval date [1] 288295 0
21/02/2008
Ethics approval number [1] 288295 0
E69/0708

Summary
Brief summary
FODMAPs are poorly absorbed sugars that putatively contribute to gastrointestinal symptoms in irritable bowel syndrome (IBS). Supporting evidence comprises confirmation of mechanisms of action, effects of acute challenge with individual FODMAPs/foods, observational studies in IBS and quiescent Crohn’s disease, randomised controlled trials of fructose and fructan rechallenges in IBS patients with controlled symptoms on a low FODMAP diet and a non-randomised comparative study.
We aim to fill evidence gaps regarding effects on symptoms over the longer term with the low FODMAP diet compared to the moderate FODMAP intake on a typical Australian diet by comparing GI symptoms in unselected IBS patients consuming such diets with those in healthy and disease controls (quiescent Crohn's disease).
Trial website
Nil
Trial related presentations / publications
- Nutrition Society of Australia conference 2011 oral presentation
- Nutrition in Medicine conference 2012 poster and oral presentation
- Australian Gastroenterology Week conference 2012 oral presentation
Public notes

Contacts
Principal investigator
Name 34886 0
Address 34886 0
Country 34886 0
Phone 34886 0
Fax 34886 0
Email 34886 0
Contact person for public queries
Name 18133 0
Emma Halmos
Address 18133 0
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 18133 0
Australia
Phone 18133 0
+61 3 9903 0233
Fax 18133 0
Email 18133 0
Emma.Halmos@monash.edu
Contact person for scientific queries
Name 9061 0
Emma Halmos
Address 9061 0
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 9061 0
Australia
Phone 9061 0
+61 3 9903 0233
Fax 9061 0
Email 9061 0
Emma.Halmos@monash.edu

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