NIPH Clinical Trials Search

Extremely low-dose antigen-specific oral immunotherapy for children with severe walnut allergy: EXLOW study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	walnut allergy
Date of first enrollment	20/05/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	After the completion of week 0 observation, parents will store the assigned test powder (0.2g or 0.02g equivalent of walnut powder (protein content: 30mg or 3mg each)) or control powder (placebo) at room temperature, and will administer it orally to the research subject (child) when using it. Observation period: 24weeks (+/-1 week)

Outcome(s)

Primary Outcome	Trend of change in walnut antigen-specific IgG4 levels
Secondary Outcome	(1) Trend of change in specific IgE levels (2) Trend of change in IgG4/IgE ratio (3) QOL

Key inclusion & exclusion criteria

Age minimum	>= 3age old
Age maximum	< 16age old
Gender	Both
Include criteria	Provisional Registration Criteria 1)Patients with a documented history of walnut allergy. 2)Patients aged 3 years or older and younger than 16 years at the time of obtaining informed consent. 3)Patients who, within the past 24 months, have exhibited objective allergic symptoms following natural accidental ingestion of walnut or a walnut oral food challenge, with an estimated or confirmed eliciting dose of 2 g or less (equivalent to 300 mg of walnut protein); or patients with a history of walnut induced anaphylaxis following natural accidental ingestion or an oral food challenge, and who have serum walnut specific IgE or Jug r 1 specific IgE levels of 3.50 kUA/L or higher measured within the past 12 months. 4)Patients for whom written informed consent for study participation has been obtained from a legally authorized representative. Full Registration Criteria 1)Patients who undergo a walnut oral food challenge within 8 weeks after provisional registration and demonstrate negative results at a total cumulative intake of 0.22 g (equivalent to 33 mg of walnut protein), defined as Sampson Grade 1 or lower, will be eligible for full registration. Patients whose symptom eliciting threshold is 33 mg cumulatively or less will be considered screen failures, and appropriate medical care will be provided at each participating medical institution as deemed necessary.
Exclude criteria	1)Patients who are currently undergoing any form of immunotherapy (including oral, epicutaneous, sublingual, or subcutaneous immunotherapy), or who are scheduled to initiate immunotherapy during the study period. 2)Patients with a previous history of walnut immunotherapy, or patients who have not been adhering to walnut avoidance. 3)Patients with a history of severe anaphylaxis following walnut ingestion, including reactions accompanied by respiratory failure or those requiring management in an intensive care unit or equivalent setting. 4)Patients who exhibited allergic symptoms of Grade 2 or higher according to the Sampson classification during a walnut oral food challenge. 5)Patients who have received systemic corticosteroid therapy within 1 month prior to obtaining informed consent. 6)Patients who are otherwise deemed ineligible for study participation at the discretion of the attending physician.