UMIN-CTR Clinical Trial

Public title

A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose :A randomized, double-blind, placebo controlled trial

Acronym

A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose

Scientific Title

A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose :A randomized, double-blind, placebo controlled trial

Scientific Title:Acronym

A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of ingestion of yogurt on the subjective evaluation of the discomfort of eyes and nose, and blood index

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Questionnaire of discomfort of eyes and nose,Diary.
Evaluate at points of 12-week and 4-week, 8-week

Key secondary outcomes

Specific IgE(RAST), IFN-Gamma, IL-13, Total IgE(RIST)

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

Ingestion of yogurt drink containing lactic acid bacteria LH strain for 12 consecutive weeks

Interventions/Control_2

Ingestion of yogurt drink without lactic acid bacteria LH strain for 12 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Subjects aged from 20 to 64 years old
(2)Subjects with discomfort of eyes and nose(sneeze,runny nose, nasal)
(3)Subjects positive for specific IgE(RAST)against house dust or mite.
(4)Subjects who are judged as healthy adult for the study by the investigator

Key exclusion criteria

(1)Subjects who routinely take foods or medicines containing of lactic acid bacteria.
(2)Subjects who routinely take foods or medicines affecting the test result
(3)Subjects who have history of
regular visits of otorhinolaryngology or planned to clinic visits
(4)Subjects who has received a diagnosis of seasonal allergic rhinitis (pollen allergy)
(5)Subjects with acute rhinitis, sinusitis or hypertrophic rhinitis
(6)Subjects with bronchial asthma
(7)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(8)Subjects who are under medication(e.g., hyposensitization)which may influence the outcome of the study
(9)Subjects with allergies to the test food in the study
(10)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function
(11)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(12)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(13)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(14)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(15)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(16)Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Fujta

Organization

MEGMILK SNOW BRAND Co.,Ltd.

Division name

Milk Science Research Institute. Food Function Laboratory

Zip code

Address

1-1-2 Minamidai,Kawagoe,Saitama,Japan

TEL

049-242-8111

Email

tfujita@meg-snow.com

Name of contact person

1st name
Middle name
Last name	Chiharu Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

c.goto@ttc-tokyo.co.jp

Institute

TTC 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

Address

Tel

Email

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

2018

Year

12

Month

23

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

2017

Year

06

Month

08

Day

Date of IRB

2017

Year

06

Month

08

Day

Anticipated trial start date

2017

Year

06

Month

18

Day

Last follow-up date

2017

Year

12

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

16

Day

Last modified on

2019

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031843