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Trial registered on ANZCTR


Registration number
ACTRN12610000524099
Ethics application status
Approved
Date submitted
23/06/2010
Date registered
24/06/2010
Date last updated
29/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of gluten as a cause of gastrointestinal symptoms and fatigue in patients who do not have coeliac disease
Scientific title
The role of wheat gluten in the genesis of gastrointestinal symptoms and fatigue in patients with non-coeliac gluten intolerance: Investigation of the gluten ‘intolerance’ threshold level.
Secondary ID [1] 252091 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-coeliac gluten intolerance 257637 0
Condition category
Condition code
Oral and Gastrointestinal 257817 257817 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
Arm 1: Whole wheat-gluten (16 grams of commercial gluten per day); and Arm 2: Whole wheat-gluten (2 grams of commercial gluten per day ).

The study is a randomised, placebo-controlled, double-blinded cross-over study design of 9 weeks duration (including a two-week run-in period at the start), where eligible volunteers will be randomly allocated to receive one of the three treatment arms for 1 week, followed by a washout period of at least 2-weeks (or until symptoms induced during the previous dietary challenge have resolved), before crossing over to the next diet.

Each volunteer will undertake all 3 treatment arms. All food will be provided where the gluten will be administered across the day in different meals (all baseline meals will be gluten-free and low in poorly absorbed fermentable carbohydrates).
Intervention code [1] 256713 0
Diagnosis / Prognosis
Comparator / control treatment
Arm 3: Placebo (16 grams per day of easily-digested rice protein)
Control group
Placebo

Outcomes
Primary outcome [1] 258674 0
The comparison of the change in mean in the overall symptom score measured on the visual analogue scale.
Timepoint [1] 258674 0
After 1 week of each study diet.
Secondary outcome [1] 264672 0
The proportion of participants demonstrating an increase in the overall symptom score measured on the visual analogue scale of at least 2 cm
Timepoint [1] 264672 0
After 1 week of each study diet.
Secondary outcome [2] 264673 0
The proportion of participants demonstrating an increase in individual symptom scores measured on the visual analogue scale of at least 2 cm
Timepoint [2] 264673 0
After 1 week of each study diet.
Secondary outcome [3] 264674 0
The change in symptom scores (individual and overall) compared with baseline symptom levels.
Timepoint [3] 264674 0
After 1 week of each study diet.
Secondary outcome [4] 264675 0
Changes during dietary treatment biomarkers (antibody titres, C-Reactive Protein, serum cytokine expression assessed in venous blood samples) and by-products of protein metabolism (ammonia, cresols and phenols assessed in faecal collections).
Timepoint [4] 264675 0
After 1 week of each study diet.
Secondary outcome [5] 264676 0
Magnitude of gluten-specific T cell responses following gluten challenge
Timepoint [5] 264676 0
After 1 week of each study diet.
Secondary outcome [6] 264677 0
Change and comparison over the treatment arms in scores on daily fatigue impact scale (FIS), cognitive function tests and activity levels
Timepoint [6] 264677 0
After 1 week of each study diet.

Eligibility
Key inclusion criteria
1. Met Rome III criteria for Irritable Bowel Syndrome (IBS) prior to implementation of gluten-free diet (GFD)
2. Current gastrointestinal (GI) symptoms well-controlled on a GFD
3. Adherent to a strict GFD for the previous 6 weeks.
4. Coeliac disease excluded by either normal duodenal histology while consuming a gluten-containing diet or by having a genotype that is inconsistent with coeliac disease (Human Leukocyte Antigen (HLA) -DQ2 and -DQ8 negative)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other significant GI disease (e.g., cirrhosis, inflammatory bowel disease) or other clinically significant co-morbidity.
2. Intake of non-steroidal anti-inflammatory drugs
3. Use of systemic immunosuppressant medication (e.g., prednisolone, methotrexate, thiopurines, anti-tumour necrosis factor drugs)
4. Excessive alcohol intake
5. Poorly controlled psychiatric disease
6. Unable to give written/informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
37
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257181 0
Government body
Name [1] 257181 0
Australian Research Council
Country [1] 257181 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Faculty Medicine, Nursing & Health Sciences
Eastern Health Clinical School, Box Hill Hospital
Level 2, 5 Arnold St, Box Hill VIC
3128
Country
Australia
Secondary sponsor category [1] 256439 0
Commercial sector/Industry
Name [1] 256439 0
George Weston Foods
Address [1] 256439 0
1 Braidwood St
Enfield
NSW 2136
Country [1] 256439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259220 0
Eastern Health Research & Ethics
Ethics committee address [1] 259220 0
Ethics committee country [1] 259220 0
Australia
Date submitted for ethics approval [1] 259220 0
23/11/2009
Approval date [1] 259220 0
27/01/2010
Ethics approval number [1] 259220 0
E65/0910

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

Contacts
Principal investigator
Name 31331 0
Address 31331 0
Country 31331 0
Phone 31331 0
Fax 31331 0
Email 31331 0
Contact person for public queries
Name 14578 0
Jess Biesiekierski
Address 14578 0
Deparment of Gastroenterology, Monash University
Eastern Health Clinical School, Box Hill Hospital
Level 2, 5 Arnold St, Box Hill
VIC 3128
Country 14578 0
Australia
Phone 14578 0
+61 3 9094 9530
Fax 14578 0
+61 3 9899 2518
Email 14578 0
Jessica.Biesiekierski@monash.edu
Contact person for scientific queries
Name 5506 0
Jess Biesiekierski
Address 5506 0
Deparment of Gastroenterology, Monash University
Eastern Health Clinical School, Box Hill Hospital
Level 2, 5 Arnold St, Box Hill
VIC 3128
Country 5506 0
Australia
Phone 5506 0
+61 3 9094 9530
Fax 5506 0
+61 3 9899 2518
Email 5506 0
Jessica.Biesiekierski@monash.edu

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.