Oral cow's milk immunotherapy combined with sublingual immunotherapy and antigen-specific IgE antigen binding affinity.

JRCT ID: jRCT1031240155

Registered date:11/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: milk allergy
• Date of first enrollment: 11/06/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Sublingual immunotherapy with skimmed milk powder

Outcome(s)

• Primary Outcome: Negative rate of 25 mL oral challenge test (2nd time)
• Secondary Outcome: Negative rate of 25 mL (1st) challenge test, rate of change in objective indicators (peripheral blood eosinophil count, serum total IgE, serum antigen-specific IgE (milk, casein, alpha gamma albumin, beta gamma globulin), antigen-specific IgG1,4, Binding-Avidity (milk), skin prick test (milk) ), safety assessment (incidence of adverse events (escalation phase, maintenance phase), adherence

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Persons who meet all of the following criteria are eligible for selection.
1) Patients with obvious cow's milk allergy.
*Obvious cow's milk allergy is defined as an immediate objective positive symptom (e.g. extensive urticaria, wheezing, coughing, dyspnoea, vomiting, diarrhoea, shock) with a threshold of less than 3 mL of milk in a food oral load test within 3 months of study initiation.
2) Patients who are eligible for sublingual immunotherapy at the start of the study.

Exclude criteria

1) Patients with poorly controlled atopic dermatitis or bronchial asthma
2) Patients with serious or potentially study-affecting diseases of the circulatory system, cranial nerves, nephrology and urinary system, hepatobiliary and pancreatic-gastrointestinal tract, etc.
3) Other patients deemed unsuitable as subjects by the principal investigator.

Related Information

• Primary Sponsor: Takanori Imai