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Trial registered on ANZCTR


Registration number
ACTRN12619000897167p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2019
Date registered
26/06/2019
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is early introduction of tree nuts in infants at high risk of food allergy feasible? The TreEAT Pilot Study: a randomised controlled trial
Scientific title
Is early introduction of tree nuts in infants at high risk of food allergy feasible? The TreEAT Pilot Study: a randomised controlled trial
Secondary ID [1] 298392 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
food allergy 313082 0
Condition category
Condition code
Inflammatory and Immune System 311569 311569 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple tree nut (cashew, almond, walnut, hazelnut) in hospital oral food challenge. Prepared by specialised allergy dietitian and administered by an allergy trained nurse and supervised by an allergist. Total dose is 20g delivered in a carrier food of the participants choice (ie fruit puree, yogurt, custard, bread, crackers) over 6 doses in a 4 hour period:
Smear, 1/8 teaspoon, ¼ teaspoon, ½ teaspoon, 1 teaspoon, approx. 2 teaspoons (remainder of dose). Total challenge dose of 20g of nut protein (approx 4 teaspoons)
Intervention code [1] 314635 0
Prevention
Comparator / control treatment
Current standard care (individual tree nut introduction via unsupervised home introduction protocol) Allergy Department Royal Children's Hospital Melbourne Home Introduction of Food Protocol, 2019. This involves introduction of each individual tree nut in a ground or meal form in a slow graded introduction process over several days. Families will have this information provided in a written format and have the process explained by the Allergy Dietitian.
Control group
Active

Outcomes
Primary outcome [1] 320275 0
Tree nut allergy/tolerance measured via clinical history and examination.
Timepoint [1] 320275 0
18mths of age
Secondary outcome [1] 371046 0
Number of adverse food reactions measured via clinical history and examination.
Timepoint [1] 371046 0
18mths of age
Secondary outcome [2] 371047 0
Severity of symptoms of adverse food reactions measured via clinical history and examination
Timepoint [2] 371047 0
18mths of age
Secondary outcome [3] 371048 0
Medical treatment required for adverse food reactions measured via clinical history and examination.
Timepoint [3] 371048 0
18mths of age
Secondary outcome [4] 371049 0
Compliance to home tree nut introduction measured via questionnaire (designed specifically for this study).
Timepoint [4] 371049 0
18mths of age
Secondary outcome [5] 371050 0
Quality of life (FASQL)
Timepoint [5] 371050 0
Baseline and 18mths of age
Secondary outcome [6] 371051 0
Skin prick test wheal size to egg
Timepoint [6] 371051 0
Baseline and 18mths of age
Secondary outcome [7] 371052 0
Tree nut (cashew, hazelnut, almond, walnut) via specific IgE serum assay.
Timepoint [7] 371052 0
Baseline and 18mths of age
Secondary outcome [8] 371536 0
Frequency of ongoing tree nut ingestion during the study measured via questionnaire (specifically designed for this study)
Timepoint [8] 371536 0
18 mths of age
Secondary outcome [9] 371539 0
Skin prick test wheal size (mm) to peanut
Timepoint [9] 371539 0
At 18mths of age
Secondary outcome [10] 371540 0
Tree nut (cashew, almond, walnut, hazelnut) component resolved diagnostics
Timepoint [10] 371540 0
At 18mths of age
Secondary outcome [11] 371541 0
Tree nut (almond, cashew, walnut and hazelnut) basophil activation test result.
Timepoint [11] 371541 0
At 18mths of age
Secondary outcome [12] 372003 0
To measure acceptability of the home tree nut introduction protocol via parent completed questionnaire (designed specifically for this study)
Timepoint [12] 372003 0
At 18 months of age
Secondary outcome [13] 372004 0
To measure acceptability of the supervised multi-nut oral food challenge via parent completed questionnaire (designed specifically for this study)
Timepoint [13] 372004 0
At 18 months of age.

Eligibility
Key inclusion criteria
- Infants >4mths and less than 11mths of age currently referred to the Royal Children's Hospital Allergy Department.
- History of likely IgE-mediated egg and/or peanut reaction as determined by RCH allergist with positive skin prick test to egg and/or peanut (>=3mm)
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
Minimum age
4 Months
Maximum age
11 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- any history of food induced anaphylaxis
- pre existing tree nut allergy
- any tree nut already tolerated (ingestion on >3 occasions without reaction)
- unable to eat solid food
- inability or unwillingness of participant or legally acceptable representative to give written informed consent.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13885 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 26657 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302932 0
Other
Name [1] 302932 0
Murdoch Children's Research Institute
Address [1] 302932 0
Flemington Rd
PARKVILLE, VIC 3052
Country [1] 302932 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Flemington Rd
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 302893 0
Individual
Name [1] 302893 0
Dr Kirsten Perrett
Address [1] 302893 0
Population Allergy
Murdoch Children's Research Institute
Flemington Rd PARKVILLE, VIC 3052
Country [1] 302893 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303496 0
Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 303496 0
Flemington Rd
PARKVILLE, VIC 3052
Ethics committee country [1] 303496 0
Australia
Date submitted for ethics approval [1] 303496 0
31/01/2019
Approval date [1] 303496 0
Ethics approval number [1] 303496 0

Summary
Brief summary
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. Little is known about tree nut allergy. Current allergy testing methods are indicative of IgE sensitisation only and are not diagnostic of food allergy. Current practice at RCH allergy clinic in children who are egg and/or peanut allergic is to advise families to introduce each individual tree nut into their child’s diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of this strategy has not been formally evaluated. This pilot study is a 2-armed, open-label, randomised, controlled trial (RCT) to assess the safety and feasibility of a supervised hospital based multi-tree nut oral food challenge (OFC) versus standard care (home introduction of individual tree nuts) in infants with egg and/or peanut allergy to reduce the risk of developing tree nut allergy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93862 0
Dr Kirsten Perrett
Address 93862 0
Population Allergy Group
Murdoch Childrens Research Institute
Flemington Rd
PARKVILLE, VIC 3052
Country 93862 0
Australia
Phone 93862 0
+61 399366278
Fax 93862 0
Email 93862 0
kirsten.perrett@mcri.edu.au
Contact person for public queries
Name 93863 0
Dr Kirsten Perrett
Address 93863 0
Population Allergy Group
Murdoch Childrens Research Institute
Flemington Rd
PARKVILLE VIC 3052
Country 93863 0
Australia
Phone 93863 0
+61 399366278
Fax 93863 0
Email 93863 0
kirsten.perrett@mcri.edu.au
Contact person for scientific queries
Name 93864 0
Dr Kirsten Perrett
Address 93864 0
Population Allergy Group
Murdoch Childrens Research Institute
Flemington Rd
PARKVILLE VIC 3052
Country 93864 0
Australia
Phone 93864 0
+61 399366278
Fax 93864 0
Email 93864 0
kirsten.perrett@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results