cow'
Conditions
Interventions
125ml citrus juice fermented with lactic acid bacteria and oral immunotherapy for cow'
s milk allergy every day for 24 weeks
125ml citrus juice without lactic acid bacteria (placebo) and oral immunotherapy for cow'
s milk allergy every day for 24 weeks
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) cow's milk allergy diagnosed by 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.
Exclusion criteria
Exclusion criteria: 1) allergy to study juice and citrus 2) Taking oral immunotherapy for the other foods except cow's milk 3) Children born before 37 weeks of gestation 4) Twin or multiple birth 5) Children who participate in the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adherence -consumed volume and days of taking the study juice of taking the study juice Feasibility -perticipation rate of the study -withdrawal rate of the study -deviation rate of the study Efficacy -the change from baseline after the end of intervention for 24 weeks in cow's milk, casein, and beta-lactoglobulin-specific IgE in serum. -the change from baseline after the end of intervention for 24 weeks in cow's milk, casein, and beta-lactoglobulin-specific IgG4 in serum. -the dose of milk intake in oral immunotherapy at the end of the intervention for 24 weeks. Exploratory -the change from baseline after the end of intervention for 24 weeks in cytokines and chemokines. -gut microbiota after the end of intervention for 24 weeks -the change from baseline after the end of intervention for 24 weeks in gut microbiota | — |
Countries
Japan
Contacts
Public ContactKiwako Yamamoto-Hanada
TOY Study Coordinating Office Division of Allergy, National Center for Child Health and Development
Outcome results
None listed