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Trial registered on ANZCTR


Registration number
ACTRN12615000542594
Ethics application status
Approved
Date submitted
16/04/2015
Date registered
28/05/2015
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of low-chemical elimination diet with a low fermentable oligo, di, mono-saccharide and polyol (low FODMAP) diet for the management of functional gastrointestinal disorders (FGID)
Scientific title
A randomized cross-over trial in adult patients with functional bowel disorders comparing the efficacy of a low-chemical elimination diet with a low-FODMAP diet for symptom control and quality of life improvement.
Secondary ID [1] 286587 0
nil
Universal Trial Number (UTN)
Trial acronym
FGID and diet study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional gastrointestinal disorders 294777 0
Condition category
Condition code
Oral and Gastrointestinal 295060 295060 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
Randomised cross-over comparison of low-chemical (low salicylates, amines, glutamates, additives) with a low FODMAP (low fermentable oligo, di, mono-saccharides and polyols) diets. Each diet will run for 3 weeks and be administered by a dietitian. No washout period is required. Improvement in symptoms would be expected to some extent after 3 weeks and participants will be allowed time at the end of the second diet (where they will maintain a low chemical diet (and low FODMAP if indicated). If no improvement after 6 weeks, participants will be returned to a normal diet. Food diaries will be utilised throughout the protocol to monitor adherence and nutritional adequacy. As part of the study, participants would consult the dietitian at randomisation, and prior to cross-over (each 30-60min). Email and phone access to the dietitian is provided ongoing.
Intervention code [1] 291645 0
Treatment: Other
Comparator / control treatment
Head-to-head comparison of low-chemical elimination diet and low-FODMAP diet
Control group
Active

Outcomes
Primary outcome [1] 294827 0
Symptom control. Questionnaires will be administered before commencing the trial, at the end of the interventions. A standard daily symptom diary will be used in conjunction with the dietary intake diary. These questionnaires are 'Patient information forms' developed by the RPAH Allergy Unit for use with all patients.
Timepoint [1] 294827 0
Symptom type, severity and frequency will be assessed by questionnaire at baseline and on completion of each intervention (weeks 3 and 6). Symptoms occurrence and severity is also recorded on a daily basis via symptom diary.
Secondary outcome [1] 314160 0
Quality of life will be assessed with a standardized IBS-QOL instrument modified for use in patients with food intolerances.
Timepoint [1] 314160 0
At baseline and after 3 weeks on each diet.

Eligibility
Key inclusion criteria
Functional bowel disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active asthma, past asthma triggered by food or drinks, history of laryngeal oedema or anaphylactoid reactions, or other gastrointestinal disorders (e.g. inflammatory bowel disease, coeliac disease)

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3702 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 9535 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 291106 0
Hospital
Name [1] 291106 0
RPAH Allergy Unit
Country [1] 291106 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Allergy Unit
Address
9-11 Layton St, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289783 0
None
Name [1] 289783 0
Address [1] 289783 0
Country [1] 289783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292685 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 292685 0
Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 292685 0
Australia
Date submitted for ethics approval [1] 292685 0
Approval date [1] 292685 0
25/03/2015
Ethics approval number [1] 292685 0
X15-0060

Summary
Brief summary
The aim is to compare the effectiveness of two widely used diets: (1) the RPAH low chemical elimination diet, and (2) the low FODMAP diet. Patients will be randomly allocated to a 3-week period on one of these diets, after which they will cross-over for a further 3 weeks on the other diet.
The main outcome measure will be symptom response. In addition to keeping a standard daily food & symptom diary, participants will be asked to complete questionnaires before, during and after the intervention period to assess impact on quality of life. Their dietary intake will also be analysed by a dietitian to ensure ongoing nutritional adequacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56298 0
Mrs Wendy Stuart-Smith
Address 56298 0
RPAH Allergy Unit
9-11 Layton St,
Camperdown NSW 2050
Country 56298 0
Australia
Phone 56298 0
+61 2 9515 3322
Fax 56298 0
Email 56298 0
[email protected]
Contact person for public queries
Name 56299 0
Wendy Stuart-Smith
Address 56299 0
RPAH Allergy Unit
9-11 Layton St,
Camperdown NSW 2050
Country 56299 0
Australia
Phone 56299 0
+61 2 9515 3322
Fax 56299 0
Email 56299 0
[email protected]
Contact person for scientific queries
Name 56300 0
Wendy Stuart-Smith
Address 56300 0
RPAH Allergy Unit
9-11 Layton St,
Camperdown NSW 2050
Country 56300 0
Australia
Phone 56300 0
+61 2 9515 3322
Fax 56300 0
Email 56300 0
[email protected]

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
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