Using common foods to treat food allergies

Using Commonly Available Food Products To Treat Food Allergy (NATASHA Study)

This study is testing whether giving kids and young adults with peanut or cow's milk allergies small amounts of these common foods can help them get used to them and reduce their allergic reactions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 3 Years to 23 Years
• Sex: All
• Sponsor: University of Southampton (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 5 sites (Leicester and 4 other locations)
• Trial ID: NCT05503446 on ClinicalTrials.gov

What this trial studies

This study aims to explore the use of commonly available food products, such as peanut and cow's milk, in oral immunotherapy to treat IgE-mediated food allergies in children and young adults. Participants aged 3 to 23 years with a history of peanut or cow's milk allergies will receive increasing doses of these allergens to promote desensitization. The study addresses the challenges of treatment compliance due to taste aversions and aims to gather longer-term data on the effectiveness and cost-effectiveness of this approach. By utilizing familiar food products, the study seeks to improve the overall experience and outcomes for patients undergoing treatment.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 3 to 23 years with a confirmed IgE-mediated allergy to peanut or cow's milk.

Not a fit: Patients with a history of severe allergic reactions requiring intensive care or those with poorly controlled asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the severity of allergic reactions and improve the quality of life for children with food allergies.

How similar studies have performed: Other studies have shown promise with oral immunotherapy for food allergies, indicating that this approach is gaining traction in the field.

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)

Where this trial is running

Leicester and 4 other locations

• University of Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
• Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
• Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle, United Kingdom (Not_yet_recruiting)
• Sheffield Children's Hospital NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
• University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Paul J Turner, FRCPCH PhD — Imperial College London
• Study coordinator: Hasan Arshad, MBBS DM FRCP

Conditions IgE-Mediated Cow Milk Allergy; Peanut Allergy