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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04801823




Registration number
NCT04801823
Ethics application status
Date submitted
12/03/2021
Date registered
17/03/2021

Titles & IDs
Public title
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy
Scientific title
Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants at High Risk of Tree Nut Allergy: The TreEat Study: a Randomised, Open-label Controlled Trial
Secondary ID [1] 0 0
70489
Universal Trial Number (UTN)
Trial acronym
TreEat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy in Infants 0 0
Nut Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Home introduction
Other interventions - Multi Nut oral food challenge

Active comparator: Home Introduction of Individual tree nuts - Current standard of care which is to advise families of infants diagnosed with peanut allergy to introduce tree nuts individually via a standardized, graded and cautious home introduction protocol. Day 1: smear of nut paste to the inside of lip; Day 2: 1/8 teaspoon; Day 3: 1/4 teaspoon; Day 4: 1/2 teaspoon; Day 5: 1 teaspoon. Repeat process with each individual tree nut.

Experimental: In hospital multi-tree nut (almond, cashew hazelnut and walnut) oral food challenge (OFC) - Infant will be booked for a 4-nut butter (Almond, Hazelnut, Walnut, and Cashew) graded and supervised OFC in the allergy clinical trials unit at the Murdoch Children's Research Institute. The nut butter contains a 1g dose of each nut protein in a total weight of 20g. Doses will be administered every 15minutes (1. Smear to inside of lip, 2.1/8 teaspoon, 3.1/4 teaspoon, 4.1/2 teaspoon, 5.1 teaspoon, 6.remainder of 20g nut butter paste) If challenge negative, infants continue home introduction of tree nuts as per written instructions provided. If challenge positive, infants will have additional SPT (for full tree nut panel) and single tree nut OFC as per protocol to determine tolerance/allergic status (and +/- home introduction recommendation) for each tree nut.


Other interventions: Home introduction
Cautious, graded introduction of individual tree nuts

Other interventions: Multi Nut oral food challenge
In hospital multi nut oral food challenge (almond, cashew, hazelnut, walnut)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age
Timepoint [1] 0 0
18 months of age
Secondary outcome [1] 0 0
Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 18 months of age
Timepoint [1] 0 0
18 months of age
Secondary outcome [2] 0 0
Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion.
Timepoint [2] 0 0
18 months of age
Secondary outcome [3] 0 0
Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion.
Timepoint [3] 0 0
18 months of age
Secondary outcome [4] 0 0
Difference between the 2 treatment arms in the number of tree nuts ingested.
Timepoint [4] 0 0
18 months of age
Secondary outcome [5] 0 0
Difference between the 2 treatment arms in the frequency of tree nuts ingested.
Timepoint [5] 0 0
18 months of age
Secondary outcome [6] 0 0
Difference between the two treatment arms in mean change from baseline of Quality of Life Scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form at 18 months of age.
Timepoint [6] 0 0
Baseline and 18 months of age
Secondary outcome [7] 0 0
Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory
Timepoint [7] 0 0
Baseline and 18 months of age
Secondary outcome [8] 0 0
Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms
Timepoint [8] 0 0
18 months of age

Eligibility
Key inclusion criteria
Infants aged greater than 4 months and less than 11 months of age diagnosed with IgE-mediated peanut allergy in conjunction with a positive SPT (=3mm) or sIgE (specific immunoglobulin E) (>0.35 kU/L)
Minimum age
4 Months
Maximum age
11 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intramuscular (IM) adrenaline.
* Pre-existing tree nut allergy (parent-reported).
* Any tree nut already tolerated (ingestion on >3 occasions without reaction of around 1 teaspoon)
* SPT or sIgE performed to any tree nuts
* Not commenced or unable to eat solid food
* Prescribed beta-blocker medication

Study design
Purpose of the study
Prevention
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
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute (MCRI) - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten Perrett, MD. PhD
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set collected for this analysis of the TreEat trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the TreEat trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research institute which has approved the proposed analysis plan.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
6 months after publication of primary outcome
Available to whom?
Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the TreEat trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04801823