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

Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Single Blind Placebo-Controlled Trial Single Blind Test - Lactobacillus strain Th1 adjuvant for sublingal allergy vaccine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007176

Enrollment

300

Registered

2012-01-31

Start date

2009-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese cedar pollen allergy

Interventions

From December 2009 to May 2010, patients of control 1 receive active treatment and 1 LAB tablet at 7 times per week. The induction/build-up phase is 3 weeks, with an increasing daliy number of the ex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Clinical history of cedar pollen-induced allergic rhinoconjunctivitis for at least 2 years 2)Positive specific IgE to cry j1/2 antigen(CAP-RAST>=class2)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Symptom-medication score	—

Secondary

Measure	Time frame
Local findings in rhinoscope Serum anti-Japanese cedar pollen specific IgE antibody Serum ECP level Lymphocyte Subsets of Peripheral Blood Mononuclear Cell (Immunophenotyping)	—

Countries

Japan

Contacts

Public ContactShigetoshi Horiguchi

Graduate School of Medicine, Chiba University Department of Otolaryngology

jibika@office.chiba-u.jp043-226-2137

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026