Using Commonly Available Food Products To Treat Food Allergy

Launched by UNIVERSITY OF SOUTHAMPTON · Aug 12, 2022

Keywords

ClinConnect Summary

The NATASHA study is a clinical trial designed to explore a new treatment approach for children and young adults with allergies to peanuts and cow's milk. The study will involve giving small, increasing amounts of these allergens in a safe and controlled way, using common food products, to help participants become less sensitive to these foods. This process is called oral immunotherapy (OIT), and the goal is to reduce the chances of serious allergic reactions in the future.

To participate, children aged 3 to 23 years old with confirmed allergies to cow's milk or peanuts can enroll, provided they meet certain health criteria. For example, they should have a history of allergic reactions to these foods but not have had severe reactions requiring intensive medical care. Participants will be closely monitored throughout the study, and researchers will gather information on the treatment's effectiveness and safety, as well as how it might be beneficial in the long term. If you’re considering this trial for your child, it’s a chance to help advance knowledge about food allergies while receiving potentially helpful treatment under medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediated food allergy to cow's milk
• • 2. Past history consistent with IgE-mediated allergy to the relevant allergen
• • 3. Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC, prior to treatment allocation
• • 4. Written informed consent (for young people under 16, consent from the parent/legal guardian (AND assent from the young person when the young person is age 6+ years)
• Exclusion Criteria:
• • 1. Required previous admission to an intensive care unit for management of an allergic reaction
• • 2. Clinically significant chronic illness (other than asthma, rhinitis or eczema)
• • 3. Moderate-severe eczema, defined as requiring more than once daily application of 1% hydrocortisone or equivalent topical calcineurin inhibitor as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
• • 4. Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the International Consensus On (ICON) Pediatric Asthma consensus), or asthma requiring treatment with \>5 days oral corticosteroids within the previous 3 months
• • 5. Previous history of eosinophilic oesophagitis
• • 6. Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 6 months
• • 7. Undergoing allergen immunotherapy for food allergy and within the first year of treatment
• 8. In CM-allergic children under consideration for desensitisation to CM:
• • currently consuming CM-containing products other than extensively-heated milk in baked foods (e.g. biscuits, cakes)
• • significant symptoms of non-IgE-mediated CM allergy within the previous 12 months
• • 9. Taking prebiotic or probiotic supplements and unwillingness to discontinue
• • 10. Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or Angiotensin Converting Enzyme (ACE) inhibitor
• • 11. Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening
• • 12. Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff in peanut-allergic children, during screening
• • 13. Objective reaction to the placebo at screening DBPCFC
• • 14. Past or current medical issue, participation in another clinical trial or other consideration, which, in the opinion of the investigator, may pose additional risks from study participation, interfere with compliance or otherwise impact on the quality or interpretation of study data
• • 15. Pregnancy
• • 16. Direct personal or commercial relationship with a member of the local study team directly involved with the conduct of the trial
• • 17. Unwilling or unable to fulfil study requirements, including the requirement for appropriate supervision following dosing at home)