UMIN-CTR Clinical Trial

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

N/A (healthy adults)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Megmilk Snow Brand Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

07

Month

10

Day

Last modified on

2021

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042491