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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007177
Receipt No. R000006021
Scientific Title Clinical study of KW oral adjuvant immunotherapy for Japanese cedar pollinosis
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 KW oral adjuvant immunotherapy for Japanese cedar pollinosis
Acronym Influence of KW oral adjuvant immunotherapy for Japanese cedar pollinosis
Scientific Title Clinical study of KW oral adjuvant immunotherapy for Japanese cedar pollinosis
Scientific Title:Acronym Influence of KW oral adjuvant immunotherapy for Japanese cedar pollinosis
Region
Japan

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

Objectives
Narrative objectives1 The efficacy and safety of Lactobacillus strain (KW3110) for patients with low levels of IgE antibody against Japanese cedar pollen (Not development of Allergic rhinitis for Japanese cedar pollen) will be determined by randomized, double-blind and placebo-controlled study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence rate of Japanese cedar pollinosis
Key secondary outcomes Serum anti-Japanese cedar pollen specific IgE antibody, Serum ECP level, Lymphocyte Subsets of Peripheral Blood Mononuclear Cell (Immunophenotyping)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 It is given the test capsule (50 mg of Lactobacillus strain (KW3110): 1 tablet per day) for 6 months before the beginning of pollen.
Interventions/Control_2 It is given the placebo tablet (50 mg of placebo: 1 capsule per day) for 6 months before the beginning of pollen.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
61 years-old >
Gender Male and Female
Key inclusion criteria 1) CAP-RAST against JCP >= class 2, 2) No clinical history of the Japanese cedar pollenosis
Key exclusion 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana,Chuo-ku, Chiba, Japan
TEL
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 Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana,Chuo-ku, Chiba, Japan
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

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

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
2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

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=R000006021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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