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

Randomised controlled comparative study of the efficacy of oral cow's milk immunotherapy in combination with sublingual immunotherapy and exploration of antigen-specific IgE as an indicator of antigen binding affinity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240155
Enrollment
50
Registered
2024-06-11
Start date
2024-06-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

milk allergy Food allergy

Interventions

Sublingual immunotherapy with skimmed milk powder
Sublingual Immnotherapy

Sponsors

Takanori Imai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Negative rate of 25 mL oral challenge test (2nd time)

Secondary

MeasureTime frame
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

Contacts

Public ContactImai Takanori

Showa University school of Medicine

ta-imai@med.showa-u.ac.jp+81-3-3784-8565

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026