Clinical study of Lactobacillus strain (KW3110) for patients with Japanese cedar pollinosis

UMIN ID: UMIN000000862

Registered date:30/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2007/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

It is given the test capsule (50 mg of Lactobacillus strain (KW3110): 1 capsule per day) for 6 months before the beginning of pollen.
It is given the placebo capsule (50 mg of placebo: 1 capsule per day) for 6 months before the beginning of pollen.

Outcome(s)

• Primary Outcome: Symptom-medication score
• Secondary Outcome: Local findings in rhinoscope, Serum anti-Japanese cedar pollen specific IgE antibody, Serum ECP level, Lymphocyte Subsets of Peripheral Blood Mononuclear Cell (Immunophenotyping)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Use of any anti-histamine drugs, anti-allergy drugs, nasal steroid drugs et al at the beginning of the study, 2) Buildup phase of immunotherapy to Japanese cedar pollen, 3) Pregnancy, potential pregnancy and lactation

Related Information

• Primary Sponsor: Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare