Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Placebo-Controlled Trial

UMIN ID: UMIN000001449

Registered date:21/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollen allergy
• Date of first enrollment: 2008/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

From December 2008 to May 2009, patients of control 1 receive active treatment and 1 LAB tablet at 5 times per week. The induction/build-up phase is 3 weeks, with an increasing daliy number of the extract drops at three consentrations.
From December 2008 to May 2009, patients of control 1 receive active treatment and 1 placebo tablet at 5 times per week. The induction/build-up phase is 3 weeks, with an increasing daliy number of the extract drops at three consentrations.
From December 2008 to May 2009, patients of control 2 receive and 1 LAB tablet at 5 times per week.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.
From December 2008 to May 2009, patients of control 2 receive and 1 placebo tablet at 5 times per week.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.

Outcome(s)

• Primary Outcome: ISymptom-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: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)The history of severe asthma 2)The history of anti-allergic drugs within 4 weeks 3)Perior history of immunotherapy with cedar pollen 4)Pregnant women and those at risk of pregnancy 5)Complication of the other nasal-paranasal disease

Related Information

• Primary Sponsor: Department of Otorhinolaryngology in Ciba University Graduate School
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare