Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis(Study3)

UMIN ID: UMIN000035115

Registered date:04/12/2018

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2018/11/27
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1)Japanese cedar pollen allergy relief rice 80g intake group (allergy rerief rice 80g once a day, for 8 weeks, 7cases)
2)the placebo group (pracebo rice 80g once a day, for 8 weeks, 3 cases)

Outcome(s)

• Primary Outcome: Japanese cedar pollen-specific T cell proliferative response at 0, 4, 8 weeks after the start of ingestion
• Secondary Outcome: 1)serum Japanese cedar pollen-specific IgE antibody level at 0, 4, 8 weeks after the start of ingestion 2)adverse events from the start to the end of ingestion

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1)those whom Principal Investigator or the sharing researchers have determined inappropriate 2)those who suffer from rice allergy or have a history of rice allergy 3)those who have received immunotherapy for cedar pollen, or have the schedule 4)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician 5)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach 6)those who are participating in other clinical research

Related Information

• Primary Sponsor: Osaka Habikino Medical Center
• Source(s) of Monetary Support: Osaka Habikino Medical Center