Efficacy of Pediococcus acidilactoci K15 strain on allergic symptoms related to Japanese cedar pollinosis during the pollen dispersal season

JRCT ID: jRCTs051190061

Registered date:16/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 15/10/2019
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Heated K15 Pediococcus acidilactici

Outcome(s)

• Primary Outcome: Total nasal symptom-medication score (Severity of allergic symptoms induced by artificial Japanese cedar dispersal evaluated by scoring system)
• Secondary Outcome: Severity of rhinitis, severity of conjunctivitis, medication score, severity of QOL disturbance, objective nasal findings, safety profile, blood test

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1.individuals aged from 12 to 64 who will give informed consent upon their will
2.individuals who had allergic symptoms such as sneezing, rhinorrhea, nasal obstruction and eye itching during Japanese cedar pollen dispersal season in the past two consecutive years
3.individuals who had shown positive IgE titer more than class II for Japanese cedar pollen in the past three years
4.individuals who can take test material every day and who live or work in Osaka Prefecture

Exclude criteria

1.Individuals who show more than class 5 titer of IgE for house dust mite or who show more than class 5 titer of IgE for pets (dogs or cats) and keep corresponding pets at home
2.Individuals who show more titer of IgE for house dust mite that that for Japanese cedar pollen
3.individuals receiving allergen (Japanese cedar pollen) immunotherapy or those who will receive allergen immunotherapy during the study
4.individuals with active diseases,thus,are judged to be inappropriate to join the study by their primary care physicians
5.individuals who are pregnant and brest-feeding and will have a plan of pregnancy during the study
6.individuals who habitually intake prebiotics or probiotics (more than 3 days in a week)
7.individuals who join other clinical studies

Related Information

• Primary Sponsor: Yamamoto Masashi
• Source(s) of Monetary Support: Kikkoman corporation