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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034239
Receipt No. R000039026
Scientific Title Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Date of disclosure of the study information 2018/09/23
Last modified on 2018/10/24

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Basic information
Public title Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Acronym Inhibition of allergy by intake of lactic acid bacteria
Scientific Title Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Scientific Title:Acronym Inhibition of allergy by intake of lactic acid bacteria
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-allergic effects of lactic acid bacteria on healthy adults who have had allergic symptoms that seems to be caused by cedar pollen
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptoms caused by cedar pollen
Key secondary outcomes Nasal cavity findings, Nasal eosinophil score, Serum cytokine etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Lactic acid bacteria, one tablet/day, 8 consecutive weeks
Interventions/Control_2 Placebo, one tablet/day, 8 consecutive weeks
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects who obtained written consent regarding participation in research
2) Healthy adults aged 20 years or over, 65 years old or younger at the time of consent acquisition
3) Subjects who do not appear symptoms of allergic rhinitis in a period of not scattering cedar pollen, and do not need the medications
4) Subjects who the cedar pollen-specific IgE value is 2 or more
5) Subjects judged as appropriate for the study by the investigator in the medical examination
Key exclusion criteria 1) Pregnant women or women with potential for pregnancy, and women who want pregnancy during this study
2) Lactating women
3) Subjects with severe disease of respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease or those with a past history
4) Subjects who have acute rhinitis, sinusitis, hypertrophic rhinitis
5) Subjects who have bronchial asthma combined
6) Those who are undergoing treatment (sublingual immunotherapy, etc.) that affects the results of the study
7) Subjects receiving treatment for antihistamines, anti-leukotriene drugs, steroids for nasal spray, oral steroids, immunotherapy
8) Subjects with milk allergy
9) Subjects who regularly intake foods rich in lactic acid bacteria (kimchi, pickles, beverages containing lactic acid bacteria, yoghurt, food for specified health uses, foods with function claims, supplements) and pharmaceuticals (Biofermin, etc)
10) Subjects who regularly intake anti-allergic foods
11) Subjects who make a blood donation of 400 ml within 12 weeks before the preliminary medical examination or that of 200 ml within 4weeks before the preliminary medical examination
12) Subjects who are estimated inappropriate to this study by the principal investigator and the principal researcher.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Enomoto
Organization NPO Japan Health Promotion Supporting Network
Division name Not applicable
Zip code
Address TE Build. 5F, 3-68, Komatsubaradori, Wakayama, 640-8269
TEL 073-432-3005
Email t-enomoto@tempo.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Saito
Organization Otsuka Pharmaceutical Co.,Ltd.
Division name Otsu Nutraceuticals Research Institute
Zip code
Address 3-31-13 Saigawa Otsu, Shiga, 520-0002
TEL 077-521-8835
Homepage URL
Email Saito.Takao@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor NPO Japan Health Promotion Supporting Network
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
2018 Year 09 Month 23 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 24 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
2018 Year 09 Month 22 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039026

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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