UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001449 |
|---|---|
| Receipt number | R000001752 |
| Scientific Title | Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Placebo-Controlled Trial |
| Date of disclosure of the study information | 2008/10/21 |
| Last modified on | 2009/12/06 16:42:26 |
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Basic information
Public title
Clinical study of Sublingal immunotherapy with Lactobacillus strain for patients with Japanese cedar pollinosis : A Randomized Placebo-Controlled Trial
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 Placebo-Controlled Trial
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
ISymptom-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)
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
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.
Interventions/Control_4
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.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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
100
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetoshi Horiguchi |
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
Homepage URL
jibika@office.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
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
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
| 2008 | Year | 10 | Month | 21 | 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
| 2008 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 21 | Day |
Last modified on
| 2009 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001752
