Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000768796
Ethics application status
Approved
Date submitted
9/07/2013
Date registered
9/07/2013
Date last updated
9/07/2013
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
None
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
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
1/08/2011
Actual
24/08/2011
Date of last participant enrolment
Anticipated
Actual
29/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287575 0
Government body
Name [1] 287575 0
National Health and Medical Research Council (NHMRC)
Country [1] 287575 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] 286325 0
None
Name [1] 286325 0
Address [1] 286325 0
Country [1] 286325 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 289549 0
Approval date [1] 289549 0
Ethics approval number [1] 289549 0
E52/1011

Summary
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

Contacts
Principal investigator
Name 41286 0
Prof Peter Gibson
Address 41286 0
The Alfred
55 Commercial Road
Melbourne, VIC 3004
Country 41286 0
Australia
Phone 41286 0
+61 3 9076 3325
Fax 41286 0
Email 41286 0
peter.gibson@monash.edu
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
Australia
Phone 41287 0
+61 3 9903 0262
Fax 41287 0
Email 41287 0
simone.peters@monash.edu
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
Australia
Phone 41288 0
+61 3 9903 0262
Fax 41288 0
Email 41288 0
simone.peters@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
SourceTitleYear of PublicationDOI
EmbaseLetter: progressive weakening of the concept that gluten has a detrimental effect on mental health and gut symptoms in the absence of coeliac disease.2022https://dx.doi.org/10.1111/apt.16963
Dimensions AIRandomised clinical trial: gluten may cause depression in subjects with non-coeliac gluten sensitivity – an exploratory clinical study2014https://doi.org/10.1111/apt.12730
N.B. These documents automatically identified may not have been verified by the study sponsor.