Tokyo Oral Immunotherapy and Probiotics for Milk allergy (TOY) Study

JRCT ID: jRCTs031180180

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Milk allergy
• Date of first enrollment: 01/03/2018
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 125ml citrus juice fermented with lactic acid bacteria and oral immunotherapy for cow's milk allergy every day for 24 weeks.

Outcome(s)

• Primary Outcome: 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

Adherence
consumed volume and days of taking the study juice
days of oral immunotherapy for cow's milk allergy

Feasibility
the participation rate of the study
the 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 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 in gut microbiota.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Ohya Yukihiro
• Secondary Sponsor: Yakult Honsha CO.,Ltd.
• Secondary ID(s): UMIN000030805