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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of gluten on gastrointestinal symptoms and mental health in people with non-coeliac gluten sensitivity.
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 mechanisms of action.
Secondary ID [1] 282798 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-coeliac gluten sensitivity 289569 0
Condition category
Condition code
Oral and Gastrointestinal 289898 289898 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Participants receive one of three dietary challenges consecutively for 3 days, followed by a minimum 3-day washout before crossing over to the next diet. Challenge food is supplemented with gluten (16g/day whole wheat gluten), whey (16g/day whey protein isolate) or not supplemented (control). All meals and snacks are supplied throughout the duration of the study and controlled for other potential inducers of symptoms (FODMAPs, dairy, food chemicals).

Dietary adherence will be assessed by entries into a tick-box diary and unused food is counted at the end of each dietary challenge. Participants are asked to document any additional foods consumed.
Intervention code [1] 287481 0
Diagnosis / Prognosis
Comparator / control treatment
Challenge 3: Control (food not supplemented)

All meals and snacks provided.
Control group

Primary outcome [1] 289958 0
The comparison of the change in the overall gastrointestinal symptom score measured using a visual analogue scale.
Timepoint [1] 289958 0
Daily on each dietary challenge
Secondary outcome [1] 303661 0
The comparison of the change in anxiety and depression scores measured using the State Trait Personality Inventory.
Timepoint [1] 303661 0
Day 3 of each dietary challenge

Key inclusion criteria
Aged >16 years of age, met Rome III criteria for IBS prior to implementation of a GFD, had currently well controlled gastrointestinal symptoms, and had been adherent to a GFD for at least the preceding six weeks. Celiac disease was excluded by either a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet and/or by the absence of the HLA-DQ2 and HLA-DQ8 haplotype.
Minimum age
16 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Other significant gastrointestinal disease (such as cirrhosis or inflammatory bowel disease); other clinically significant co-morbidity; intake of non-steroidal anti-inflammatory agents; use of systemic immunosuppressant medication; poorly controlled psychiatric disease; excessive alcohol intake; pregnancy; or inability to give written informed consent.

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 287575 0
Government body
Name [1] 287575 0
National Health and Medical Research Council (NHMRC)
Address [1] 287575 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 287575 0
Primary sponsor type
Monash University
Faculty Medicine, Nursing & Health Sciences
Eastern Health Clinical School, Box Hill Hospital
Level 2, 5 Arnold St, Box Hill VIC
Secondary sponsor category [1] 286325 0
Name [1] 286325 0
Address [1] 286325 0
Country [1] 286325 0

Ethics approval
Ethics application status
Ethics committee name [1] 289549 0
Eastern Health Research & Ethics
Ethics committee address [1] 289549 0
Eastern Health, Level 4, 5 Arnold St, Box Hill,
Victoria 3128
Ethics committee country [1] 289549 0
Date submitted for ethics approval [1] 289549 0
Approval date [1] 289549 0
Ethics approval number [1] 289549 0

Brief summary
The purpose of this study is to examine the effect of gluten on gastrointestinal symptoms and mental health in those with NCGS. It is hypothesised that a major effect of gluten in those with NCGS is on mental health and not necessarily on GI symptoms.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 41286 0
Prof Peter Gibson
Address 41286 0
The Alfred
55 Commercial Road
Melbourne, VIC 3004
Country 41286 0
Phone 41286 0
+61 3 9076 3325
Fax 41286 0
Email 41286 0
Contact person for public queries
Name 41287 0
Ms Simone Peters
Address 41287 0
The Alfred Centre
Block B, Level 6
99 Commercial Road
Melbourne, VIC 3004
Country 41287 0
Phone 41287 0
+61 3 9903 0262
Fax 41287 0
Email 41287 0
Contact person for scientific queries
Name 41288 0
Ms Simone Peters
Address 41288 0
The Alfred Centre
Block B, Level 6
99 Commercial Road
Melbourne, VIC 3004
Country 41288 0
Phone 41288 0
+61 3 9903 0262
Fax 41288 0
Email 41288 0

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