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Recruitment status Completed
Unique ID issued by UMIN UMIN000007176
Receipt No. R000003482
Scientific Title Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Single Blind Placebo-Controlled Trial Single Blind Test
Date of disclosure of the study information 2012/01/31
Last modified on 2012/01/31

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Basic information
Public title Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Single Blind Placebo-Controlled Trial
Single Blind Test
Acronym Lactobacillus strain Th1 adjuvant for sublingal allergy vaccine
Scientific Title Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Single Blind Placebo-Controlled Trial
Single Blind Test
Scientific Title:Acronym Lactobacillus strain Th1 adjuvant for sublingal allergy vaccine
Region
Japan

Condition
Condition Japanese cedar pollen allergy
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Study the efficacy and safety of Lactobacillus strain(LAB) Th1 adjuvant for the sublingal immunotherapy(SLIT) of patients with Japanese cedar pollinosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Symptom-medication score
Key secondary outcomes Local findings in rhinoscope
Serum anti-Japanese cedar pollen specific IgE antibody
Serum ECP level
Lymphocyte Subsets of Peripheral Blood Mononuclear Cell (Immunophenotyping)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 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 extract drops at three consentrations.
Interventions/Control_2 From December 2009 to May 2010, patients of control 1 receive active treatment and 1 placebo tablet at 7 times per week. The induction/build-up phase is 3 weeks, with an increasing daliy number of the extract drops at three consentrations.
Interventions/Control_3 From December 2009 to May 2010, patients of control 2 receive and 1 LAB tablet at 7 times per week.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.
Interventions/Control_4 From December 2009 to May 2010, patients of control 2 receive and 1 placebo tablet at 7 times per week.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key 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)
Key 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
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Chiba University Graduate School
Division name Department of Otorhinolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL 043-226-2137
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigetoshi Horiguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Otolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku, Chiba, 260-8677
TEL 043-226-2137
Homepage URL http://orl-web2.m.chiba-u.jp/
Email jibika@office.chiba-u.jp

Sponsor
Institute Dept. of Otolaryngology, Graduate School of Medicine,
Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 31 Day
Last modified on
2012 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003482


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