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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030382
Receipt No. R000034685
Scientific Title Evaluation of improvement of arious symptoms of hay fever by intake of lactic acid bacteria-containing food Improvement of various symptoms of hay fever
Date of disclosure of the study information 2018/01/13
Last modified on 2018/12/26

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Basic information
Public title Evaluation of improvement of arious symptoms of hay fever by intake of lactic acid bacteria-containing food
Improvement of various symptoms of hay fever
Acronym Improvement of various symptoms of hay fever
Scientific Title Evaluation of improvement of arious symptoms of hay fever by intake of lactic acid bacteria-containing food
Improvement of various symptoms of hay fever
Scientific Title:Acronym Improvement of various symptoms of hay fever
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of various symptoms of hay fever
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire survey about various symptoms of hay fever before ingestion and after the end of ingestion period
Key secondary outcomes Blood test
Urine recovery (at our laboratory)
Doctor's findings and evaluations
Health diary
Doctor's findings and evaluations (for health diary)
Measurement of blood pressure and pulse

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 Treatment
Type of intervention
Food
Interventions/Control_1 Test food: ingestion of food ontaining lactic acid bacteria
2 tablets/day, 12 weeks
Interventions/Control_2 Placebo: intake of food not ontaining lactic acid bacteria
2 tablets/day, 12 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
59 years-old >=
Gender Male and Female
Key inclusion criteria Japanese males and females aged 20 to 59 years old at the time of acquiring consent

Persons who have been aware of various symptoms of Japanese cedar pollinosis for 2 years or more, or have a history of cedar pollinosis (mild to moderate) for 2 years or more

Persons with symptoms of cedar pollinosis (sneezing, runny nose, stuffy nose, eye itching) in the past 2 years

Persons who do not currently develop cedar pollinosis
Key exclusion criteria Persons undergoing treatment for perennial rhinitis

Persons undergoing hyposensitization therapy or hospital therapy for hay fever (excluding drug therapy)

Persons who are taking steroids in hay fever drug therapy (excluding other antiallergic drugs and OTC drugs)

Persons who are suffering from specific diseases and are undergoing outpatient medication treatment (excluding hay fever)

Persons who are routinely taking medicines (lactobacillus preparations etc.) that are likely to affect the test results, or taking health foods (supplements that describe effectiveness against hay fever, but not foods such as yoghurt)

During pregnancy or possibly pregnant, and those who are breastfeeding

Persons who are likely to have allergic symptoms due to the test food component

Persons participating in other clinical trials

Persons who have a history of serious liver disorder, renal disorder, heart disease

Persons who have a history of hepatitis or who are currently suffering from hepatitis

Persons with advanced anemia

Persons who are taking antiallergic drugs or being treated for atopic dermatitis, asthma, etc.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Asahi Calpis Wellness Co., LTD.
Organization
Division
Category of Funding Organization Profit 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
2018 Year 01 Month 13 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
2017 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 13 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
2017 Year 12 Month 13 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034685

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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