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
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy in Infants Nut Allergy||Other: Home introduction Other: Multi Nut oral food challenge||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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:
- 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
- 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.
- Inconclusive -has an unknown outcome as ingestion has not occurred and participant declines OFC.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Vicki McWilliam, MND.PhDfirstname.lastname@example.org|
|Contact: Kirsten Perrett, MD. PhDemail@example.com|
|Principal Investigator:||Kirsten Perrett, MD. PhD||Murdoch Children's Research Institute|