ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non-coeliac gluten sensitivity

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Oral and Gastrointestinal

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]

Diagnosis / Prognosis

Intervention code [2]

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]

Change in psychological state following the consumption of gluten. Psychological state will be assessed using the Depression Anxiety and Stress Scale

Timepoint [1]

Following treatment exposure (day 14)

Primary outcome [2]

Change in psychological state following the consumption of gluten. Psychological state will be assessed using the State Trait Personality Inventory

Timepoint [2]

Following treatment exposure (day 14)

Primary outcome [3]

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]

Following treatment exposure (day 14)

Secondary outcome [1]

Primary outcome: Change in cognitive function following the consumption of gluten. Cognitive function will be assessed using the Subtle Cognitive Impairment Test

Timepoint [1]

Primary timepoint: Following treatment exposure (day 14)

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1/16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Andrea Joy Logan Scholarship

Address [2]

Provided by a private family

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Ethics and Research Governance

Ethics committee address [1]

The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2012

Approval date [1]

17/09/2012

Ethics approval number [1]

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

Prof Peter Gibson

Address

Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61, 03, 9076 3325

Fax

peter.gibson@monash.edu

Contact person for public queries

Name

Simone Peters

Address

Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61, 03, 9903 0262

Fax

simone.peters@monash.edu

Contact person for scientific queries

Name

Simone Peters

Address

Department of Gastroenterology
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61, 03, 9903 0262

Fax

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

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