Exposure Frequency of Allergen in oral ImmunoTherapy

JRCT ID: jRCTs041180050

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Food allergy
• Date of first enrollment: 06/06/2017
• Target sample size: 40
• Study type: Interventional
• Intervention(s): the participants in frequent group intake the allergic food daily in low dose oral immunotherapy. the participants in intermittent group intake the allergic food twice weekly in low dose oral immunotherapy.

Outcome(s)

Primary Outcome

Difference of amount of intake in oral food challenge after 12 +- 2 months from start of low dose oral immunotherapy between frequent
(daily intake) group and intermittent (twice weekly intake) group.

• Secondary Outcome: Primary outcome which divided into subgroup of egg allergy and milk allergy. Difference of Egg white and ovomucoid-sIgE or milk and casein-sIgE after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups. Difference of Egg white and ovomucoid-sIgE or milk and cazein-sIgG4 after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups. Difference of increasing rate of amount of intake in oral food challenge from before the OIT to after the OIT between the frequent group and the intermittent group. Difference of increasing rate of ovomucoid-sIgE in egg allergy and milk-sIgE in milk allergy from before the OIT to after the OIT between the frequent group and the intermittent group. Difference of the FAQ after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group. Difference of the VAS scale for degree of difficulty of intake the foods after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group.

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 6age old
• Gender: Both

Include criteria

Children aged 6 months or older, 6 years or younger
Children who were diagnosed with a positive by open oral food challenge (OFC) with boiled egg white / milk, which total dose of 1-10 g. Excluding positive only for the symptoms around the oral cavity.
Children who can be Track one year and track confirmation OFC one year later.
A person who consented to the study by a substitute person who is a parental author in writing.

• Exclude criteria: Children already doing oral immunotherapy for the relevant foods, including irregular processed goods. Children who intake the other allergic food for oral immunotherapy within 2 hours of food intake for this trial. Those with poor control of atopic dermatitis and bronchial asthma. Children with chronic urticaria. Children who is planning to move within 1 year. The cases who have serious complications and doctor determines that it is inappropriate for this study

Related Information

• Primary Sponsor: Natsume Osamu
• Secondary ID(s): UMIN000026266