Tokyo Oral Immunotherapy and Probiotics for Milk allergy (TOY) Study
- Conditions
- Milk allergy
- Registration Number
- JPRN-jRCTs031180180
- Lead Sponsor
- Ohya Yukihiro
- Brief Summary
As the primary outcome, the proportion of children showing improvement at the threshold dose to cow's milk determined by OFC at the end of the intervention period had no significant differences between LP0132-fermented juice group and placebo group. The adherence to the intake of citrus juice fermented with LP0132 was good. It was considered safe to add citrus juice fermented with LP0132 to cow's milk oral immunotherapy, because there was no difference in the occurrence of AEs compared with placebo group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 61
1) Cow's milk allergy diagnosed by an oral food challenge test.
2) Children who have a plan to take oral immunotherapy for cow's milk allergy.
3) 1-18 years old children with parental signed informed consent.
4) Voluntary willingness and ability to comply with the study requirements and procedure after obtaining informed consent.
1) Allergy to study juice and citrus.
2) Taking oral immunotherapy for the other foods except for cow's milk.
3) Children born before 37 weeks of gestation.
4) Twin or multiple births.
5) Children who participate in other clinical studies.
6) Children whose siblings participate in this study.
7) Taking immunosuppressive agents and/or oral and/or intravenous steroids.
8) Children whose family may not complete all study visits because of house-moving.
9) Parents unable to understand Japanese.
10) Children with any severe comorbidity.
11) Children judged as inappropriate for the study by a study doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of participants who were improved on their threshold dose to cow's milk provoked with oral food challenge test after completing the intervention for 24 weeks.
- Secondary Outcome Measures
Name Time Method Adherence<br>consumed volume and days of taking the study juice <br>days of oral immunotherapy for cow's milk allergy<br><br>Feasibility<br>the participation rate of the study<br>the withdrawal rate of the study<br>deviation rate of the study<br><br>Efficacy<br>the change from baseline after the end of intervention for 24 weeks in cow's milk, casein and beta-lactoglobulin-specific IgE in serum.<br>the change from baseline after the end of intervention for 24 weeks in casein and beta-lactoglobulin-specific IgG4 in serum.<br>the dose of milk intake in oral immunotherapy at the end of the intervention for 24 weeks.<br><br>Exploratory<br>the change from baseline after the end of intervention for 24 weeks in cytokines and chemokines.<br>gut microbiota after the end of intervention for 24 weeks in gut microbiota.