UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Acronym	Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Scientific Title	Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Scientific Title:Acronym	Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effect of a food containing lactic acid bacteria to eyes and nose and its safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]The discomfort of eyes and nose in the daily life (JRQLQ NO.1, level of allergic rhinitis, level of local findings, eye- and nose- symptoms based on subject's diary, and effect measurement) (Screening, Week 0, Week 4, Week 8, Week 12, Week 16).
Key secondary outcomes	*Secondary outcomes [1]Japanese edition of Profile of Mood States (2nd edition) (Week 0, Week 8, Week 16). [2]Nasal eosinophil count (Screening, Week 4, Week 8, Week 12, Week 16). [3](1)Eosinophil count, (2)nonspecific IgE, (3)specific IgE, (4)thymus and activation-regulated chemokine. [4]Saliva sIgA (Week 0, Week 8, Week 16). (1)Week 0, Week 4, Week 8, Week 12, Week 16. (2)Screening, Week 4, Week 8, Week 12. (3)Screening, Week 8, Week 16. (4)Week 0, Week 8, Week 16. *Safety [1]Hematologic test (Screening, Week 0, Week 8, Week 16). [2]Blood biochemical test (Screening, Week 0, Week 8, Week 16). [3]Urine analysis (Screening, Week 0, Week 8, Week 16). [4]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12, Week 16). [5]Weight, body fat percentage, BMI (Week 0). [6]Doctor's questions (Week 0, Week 4, Week 8, Week 12, Week 16). *Other indexes [1]Questionnaire for allergic rhinitis (Week 0). [2]Subject's diary(From 3 days prior to the first day of ingestion of a test material to the last day of the test).

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	Oral intake of the test product (1 piece in a day; 16 weeks).
Interventions/Control_2	Oral intake of the placebo product (1 piece in a day; 16 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]Japanese males and females aged 20-65 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with allergic rhinitis-symptoms. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC). [2]Individuals using medical products. [3]Individuals who are a patient of or have a history of bronchial disease. [4]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollinosis). [6]Individuals who are sensitive to a test food. [7]Individuals who are sensitive to foods, and medical products. [8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30 kg/cm2 [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who have a habit of intaking fermented milk food (over 3 times in a week). [13]Individuals who cannot restrict to eat bactic acid bacteria rich food after informed consent. [14]Individuals who had a habit to ingest bifidobacteria enriched food or food for specified health uses or foods with Function Claims which adopt to ease allergy symptoms in the past 1 month or will ingest those foods during the test period. [15]Individuals who excessively take alcohol expressed in an amount of alcohol over 60g/day. [16]Individuals whose life style will change during the test period. [17]Individuals who are or are possibly pregnant, or are lactating. [18]Individuals who participated in other clinical studies in the past 3 months. [19]Individuals who are or whose family is an employee of a health food company. [20]Individuals judged inappropriate for the study by the principal.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.c.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Megmilk Snow Brand 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	Ueno-Asagao Clinic Ethical Review Committee
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.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 11 Month 02 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	2019 Year 06 Month 24 Day
Date of IRB	2019 Year 06 Month 26 Day
Anticipated trial start date	2019 Year 08 Month 17 Day
Last follow-up date	2019 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 10 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042491