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Trial registered on ANZCTR


Registration number
ACTRN12614000726651
Ethics application status
Approved
Date submitted
19/06/2014
Date registered
8/07/2014
Date last updated
8/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of wheat gluten in the genesis of gastrointestinal symptoms and mental health in patients with non-coeliac gluten sensitivity: Understanding the mechanism of action.
Scientific title
The role of wheat gluten in the genesis of gastrointestinal symptoms and mental health in patients with non-coeliac gluten sensitivity: Understanding the mechanism of action.
Secondary ID [1] 284836 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-coeliac gluten sensitivity 292226 0
Condition category
Condition code
Diet and Nutrition 292560 292560 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 292620 292620 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
Food is supplemented with gluten: Participants will be asked to consume 2 muesli bars per day for two weeks. Each muesli bar will contain 8g of gluten. Participants will keep a food diary to monitor compliance. A two week 'wash out' period will be applied between treatment arms.
Intervention code [1] 289630 0
Diagnosis / Prognosis
Intervention code [2] 289631 0
Behaviour
Comparator / control treatment
Food is not supplemented (placebo): Participants will be asked to consume 2 muesli bars per day for two weeks. The muesli bars will not have any additional supplements.
Control group
Placebo

Outcomes
Primary outcome [1] 292423 0
Change in psychological state following the consumption of gluten. Psychological state will be assessed using the Depression Anxiety and Stress Scale
Timepoint [1] 292423 0
Following treatment exposure (day 14)
Primary outcome [2] 292500 0
Change in psychological state following the consumption of gluten. Psychological state will be assessed using the State Trait Personality Inventory
Timepoint [2] 292500 0
Following treatment exposure (day 14)
Primary outcome [3] 292501 0
Change in psychological state following the consumption of gluten. Psychological state will be assessed using the Irritable Bowel Syndrome Quality of Life Questionnaire
Timepoint [3] 292501 0
Following treatment exposure (day 14)
Secondary outcome [1] 308907 0
Primary outcome: Change in cognitive function following the consumption of gluten. Cognitive function will be assessed using the Subtle Cognitive Impairment Test
Timepoint [1] 308907 0
Primary timepoint: Following treatment exposure (day 14)
Secondary outcome [2] 309276 0
Change in gastrointestinal symptoms following the consumption of gluten. Gastrointestinal symptoms will be assessed using a 100mm visual analogue scale. Gastrointestinal symptoms will be reported as a composite secondary outcome.
Timepoint [2] 309276 0
Following treatment exposure (day 14)

Eligibility
Key inclusion criteria
(1) Following a gluten-free diet has relieved gut symptoms
(2) Following a gluten-free diet makes patient 'feel better'
(3) Patient has had coeliac disease excluded
(4) Patient is currently adherent to a gluten-free diet
(5) Patient has well-controlled symptoms on a gluten-free diet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Marsh 1 or 2 lesions
(2) Other significant gastrointestinal disease
(3) Other clinically significant co-morbidity
(4) Psychiatric disease
(5) Pregnancy
(6) Alcoholism

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)
Participants who meet inclusion criteria will be invited to participate. Allocation of the subject for inclusion in the trial will be based on central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
22/04/2014
Date of last participant enrolment
Anticipated
1/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8316 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 289443 0
Government body
Name [1] 289443 0
National Health and Medical Research Council
Country [1] 289443 0
Australia
Funding source category [2] 289444 0
Other
Name [2] 289444 0
Andrea Joy Logan Scholarship
Country [2] 289444 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 288133 0
None
Name [1] 288133 0
Address [1] 288133 0
Country [1] 288133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291202 0
The Alfred Ethics and Research Governance
Ethics committee address [1] 291202 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia
Ethics committee country [1] 291202 0
Australia
Date submitted for ethics approval [1] 291202 0
28/06/2012
Approval date [1] 291202 0
17/09/2012
Ethics approval number [1] 291202 0
232/12

Summary
Brief summary
Gluten is believed to be poorly tolerated by many Australians and is often blamed for causing a wide range of gastrointestinal and psychological symptoms. Commonly reported gastrointestinal symptoms include; abdominal pain, bloating, flatulence and altered bowel habit, as frequently reported by people suffering from irritable bowel syndrome. Commonly reported psychological symptoms include; anxiety, depression and a reduction in quality of life.

The best studied ‘gluten intolerance’ is coeliac disease. Coeliac disease is an auto-immune condition that occurs in 1% of the Australian population. The only available treatment for coeliac disease is life-long strict avoidance of gluten containing foods (including wheat, rye and barley). While the average daily gluten intake in a Western diet is 10-20 g (equivalent to 2-5 slices of wheat-bread), in people with coeliac disease, 50 mg (equivalent to 1/100th of one slice of wheat-bread) gluten can cause damage to the lining of the small intestine.

Non-coeliac Gluten Sensitivity:
There is another (much larger) group of individuals, however, who believe that gluten can also cause these types of symptoms and yet, after extensive investigations by doctors and specialists, are shown not to have coeliac disease. This group of people are often referred to as having ‘non coeliac gluten sensitivity’. This condition, however, is very poorly understood and recognised by the medical profession.

Evidence for the Existence of Non-coeliac Gluten Sensitivity:
Recently completed dietary studies undertaken by our research team have found conflicting evidence for the induction of gastrointestinal symptoms following the ingestion of gluten in people believing they have ‘non-coeliac gluten sensitivity’. While an original study found good evidence that gluten can indeed cause gastrointestinal symptoms in some individuals who do not have coeliac disease this finding was not confirmed in subsequent studies.

Furthermore, our most recent study showed convincing evidence for a specific effect of gluten on mental health. In this study results indicated that short term exposure to gluten specifically induced current feelings of depression. Such findings suggest that a major effect of gluten amongst this population may be on mental health and not necessarily on gastrointestinal symptoms. This finding would also explain why participants report feeling better on the gluten-free diet despite the continuation of gastrointestinal symptoms.

Outcomes and Significance:
The purpose of this study is to investigate the role that gluten has in causing gastrointestinal symptoms and changes to mental health in people who believe they have ‘non-coeliac gluten sensitivity’. The results from this study will provide us with a more comprehensive understanding of the relationship between gluten and its influence on gastrointestinal symptoms and mental health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49334 0
Prof Peter Gibson
Address 49334 0
Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 49334 0
Australia
Phone 49334 0
+61, 03, 9076 3325
Fax 49334 0
Email 49334 0
[email protected]
Contact person for public queries
Name 49335 0
Ms Simone Peters
Address 49335 0
Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 49335 0
Australia
Phone 49335 0
+61, 03, 9903 0262
Fax 49335 0
Email 49335 0
[email protected]
Contact person for scientific queries
Name 49336 0
Ms Simone Peters
Address 49336 0
Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 49336 0
Australia
Phone 49336 0
+61, 03, 9903 0262
Fax 49336 0
Email 49336 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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