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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041755
Receipt No. R000047659
Scientific Title The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/11

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Basic information
Public title The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Acronym The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Scientific Title The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Scientific Title:Acronym The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect on nasal and ocular symptoms associated with mites and house dust of intake of food containing lactic acid bacteria for 8 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) QOL questionnaire
(2) Diary of discomfort of eyes and nose
Key secondary outcomes (1) Specific IgE (house dust and mites)
(2) Salivary sIgA concentration, salivary sIgA secretion rate
(3) Medical examination for check subjects nasal condition

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 Ingestion of the test product for 8 consecutive weeks.
Interventions/Control_2 Ingestion of the placebo for 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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1)Males and females from 20 to 64 years of age
(2)Subjects who have frequently presence of nasal discomfort (e.g. sneeze, runny nose, stuffy nose, etc.)
(3)Subjects who have positive for specific IgE against house dust or mites
(4)Subjects who are judged as healthy person or person with mild symptoms by the investigator
(5)More than half of the whole subjects will be selected from healthy person (not using antiallergic drug).
Key exclusion criteria (1) Subjects who are constantly using drugs or health food affecting nasal and ocular symptoms
(2) Subjects who frequently visit a otorhinology
(3) Subjects who have severe nasal symptoms
(4) Subjects who are complicated by bronchial asthma
(5) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, or metabolic disease)
(6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(7) Subjects who are under medication which may influence the outcome of the study (e.g. specific desensitization therapy)
(8) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care
(9) Subjects who have oral or dental problems with bleeding or develops the trouble at least once a week
(10) Subjects who bleed their teeth at least once a week when brush
(11) Night and day shift worker or manual laborer
(12) Subjects who are habitually vigorous exercise (include professional athlete)
(13) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period
(14) Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function.
(15) Subjects having possibilities for emerging allergy related to the study
(16) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(17) Subjects who have participated in other clinical studies
(18) Subjects who intend to become pregnant or lactating
(19) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(20) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Uchida
Organization Yotsuba Milk Products Co., Ltd.
Division name Reserch Division R&D Center
Zip code 061-1264
Address 465-1, Wattsu, Kitahiroshima-shi, Hokkaido
TEL 011-377-5561
Email uchida_k@yotsuba.co.jp

Public contact
Name of contact person
1st name Tamaki
Middle name
Last name Furuhata
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 150-0021
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email t.furuhata@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization Yotsuba Milk Products 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 Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguro-ku, Tokyo
Tel 03-6453-2712
Email t.saito@ttc-smo.jp

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
2020 Year 09 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 20 Day
Date of IRB
2020 Year 08 Month 20 Day
Anticipated trial start date
2020 Year 09 Month 12 Day
Last follow-up date
2020 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047659

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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