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The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy (TreEat)

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ClinicalTrials.gov Identifier: NCT04801823
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

Brief Summary:
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy. Current practice in many Australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), 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 an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. This trial is a 2-armed, open-label, randomized, controlled trial (RCT) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (OFC) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.

Condition or disease Intervention/treatment Phase
Food Allergy in Infants Nut Allergy Other: Home introduction Other: Multi Nut oral food challenge Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Home introduction
Cautious, graded introduction of individual tree nuts

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: Multi Nut oral food challenge
In hospital multi nut oral food challenge (almond, cashew, hazelnut, walnut)




Primary Outcome Measures :
  1. Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age [ Time Frame: 18 months of age ]

    Tree nut allergy outcomes at 18 months will be defined as:

    1. Allergic - has evidence of tree nut sensitization (SPT>=3mm) and has had a reaction consistent with IgE (immunoglobulin E) mediated food allergy OR positive formal OFC
    2. Tree nut tolerant- successfully tolerated the tree nut at home on more than 3 occasions of at least 1 teaspoon of nut per occasion OR has had a negative formal OFC.
    3. Inconclusive -has an unknown outcome as ingestion has not occurred and participant declines OFC.


Secondary Outcome Measures :
  1. Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 18 months of age [ Time Frame: 18 months of age ]
    Peanut allergy will be defined as peanut sensitization (SPT >=3mm) AND has had a reaction consistent with IgE mediated food allergy since randomization OR positive formal OFC

  2. Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion. [ Time Frame: 18 months of age ]
    Number and severity of adverse events (AE) as assessed by standardised predetermined criteria, related to tree nut ingestion from randomization to 18 months of age collected via parent questionnaire and medical history.

  3. Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion. [ Time Frame: 18 months of age ]
    Number and severity of solicited AEs as assessed by standardized predetermined criteria, related to tree nut ingestion from randomization to 18 months of age collected via parent questionnaire and medical history.

  4. Difference between the 2 treatment arms in the number of tree nuts ingested. [ Time Frame: 18 months of age ]
    Parent reported tree nut ingestion history based on questionnaire at baseline and 18 months of age. 0-8 tree nuts and the higher the number of tree nuts the better.

  5. Difference between the 2 treatment arms in the frequency of tree nuts ingested. [ Time Frame: 18 months of age ]
    Parent reported tree nut ingestion history based on questionnaire at baseline and 18 months of age. Range will be never to daily with higher frequency better.

  6. 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. [ Time Frame: Baseline and 18 months of age ]
    The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy. FAQLQ-PF (Parent Form), completed by parents of children aged 0-12 years consists of 30 items over 3 domains (emotional impact, food anxiety, social and dietary restrictions). Total and domain scores are calculated by dividing the sum of completed items by the number of completed items. Questions are based on a 6 point Likert scale with higher scores indicating greater impact on quality of life

  7. Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory [ Time Frame: Baseline and 18 months of age ]
    The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. The total score ranges from 0-63 with higher scores positively correlated with higher levels of anxiety.

  8. Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms [ Time Frame: 18 months of age ]
    Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions from randomization to 18 months of age.



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Ages Eligible for Study:   4 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801823


Contacts
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Contact: Vicki McWilliam, MND.PhD +61393457660 vicki.mcwilliam@mcri.edu.au
Contact: Kirsten Perrett, MD. PhD kirsten.perrett@mcri.edu.au

Locations
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Australia, Victoria
Murdoch Children's Research Institute (MCRI) Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Vicki McWilliam, PhD    0418588953    vicki.mcwilliam@rch.org.au   
Contact: Kirsten Perrett, MD, PhD       kirsten.perrett@rch.org.au   
Sponsors and Collaborators
Murdoch Childrens Research Institute
Investigators
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Principal Investigator: Kirsten Perrett, MD. PhD Murdoch Children's Research Institute
Publications:

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Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT04801823    
Other Study ID Numbers: 70489
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months after publication of primary outcome
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murdoch Childrens Research Institute:
food allergy
nut allergy
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity