UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 04 Month 01 Day

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