Efficacy and safety of TGF-rich food in oral Immunotherapy for milk allergy
- Conditions
- Food allergy (milk)food allergy
- Registration Number
- JPRN-jRCTs031180391
- Lead Sponsor
- Fujisawa Takao
- Brief Summary
To test possible efficacy of an immunomodulatory TGF-containing milk product in combination with oral immunotherapy for milk allergy, a randomized placebo-controlled clinical trial was performed. A total of 14 patients were enrolled in the study. All the patients in TGF group (100%) achieved initial desensitization status, whereas 63% in placebo group achieved desensitization. Adverse events caused by OIT tended to be fewer in TGF group than placebo group. The preliminary result may warrant further study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
1.IgE-mediated milk allergy
2.Immediate allergic symptoms are induced in oral milk challenge at cumulative dose of milk more than 3 ml and 25 ml or less
3. Written informed consent by a guardian and informed ascent by a participant(child)
Severe anaphylactic symptoms at oral milk challenge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients who acquire tolerance to 25 ml of milk fter slow oral immunotherapy (toleranc= unresponsiveness to 25 ml after 2 weeks of milk avoidance)
- Secondary Outcome Measures
Name Time Method umber of patients who reach 25 ml of daily milk intake (desensitization) during slow oral immunotherapy