UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007177 |
|---|---|
| Receipt number | 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 13:54:09 |
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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
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
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006021
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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