Efficacy of Pediococcus acidilactoci K15 strain on allergic symptoms related to Japanese cedar pollinosis induced by artificial exposure

JRCT ID: jRCTs051190046

Registered date:06/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 06/09/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): K15 Pediococcus acidilactici

Outcome(s)

• Primary Outcome: Total nasal symptom score (Severity of allergic symptoms induced by artificial Japanese cedar dispersal evaluated by scoring system), VAS score of symptomatic severity
• Secondary Outcome: Severity of rhinitis, Severity of conjunctivitis, objective nasal mucosal findings, amounts of nasal discharge

Key inclusion & exclusion criteria

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

Include criteria

1.individuals aged from 20 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 show positive IgE titer more than class II for Japanese cedar pollen by RAST

Exclude criteria

1.individuals receiving allergen (Japanese cedar pollen) immunotherapy or those who will receive allergen immunotherapy during the study
2.individuals with active diseases and judged to be inappropriate to join the study by their primary care physicians
3.individuals who are pregnant and brest-feeding or will have a plan of pregnancy during the study
4.individuals who habitually intake prebiotics or probiotics (more than 3 days in a week)
5.individuals who join other clinical studies
6.individuals who take anti-allergic drugs before or during the study

Related Information

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