UMIN-CTR Clinical Trial

Public title

Study to Determine the Effects of Continuous Intake of fermented milk drink on Cold-Like Symptoms and immunity index.

Acronym

Study to Determine the Effects of Continuous Intake of fermented milk drink on Cold-Like Symptoms and immunity index.

Scientific Title

Study to Determine the Effects of Continuous Intake of fermented milk drink on Cold-Like Symptoms and immunity index.

Scientific Title:Acronym

Study to Determine the Effects of Continuous Intake of fermented milk drink on Cold-Like Symptoms and immunity index.

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of cold-like symptom onset and immunity index of peripheral blood by the intake of a fermented milk drink containing lactic acid bacteria.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence rate of upper respiratory tract infection (cold) like symptoms

Key secondary outcomes

Severity of upper respiratory tract infection (cold) like symptoms at onset
Immunity index of peripheral blood
Questionnaire on physical condition

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

Consumption of a fermented milk drink (1 bottle a day) for 4 weeks

Interventions/Control_2

Consumption of an unfermented milk drink (1 bottle a day) for 4 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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Males and females aged 20 to below 60 years at the time of consent acquisition.
2. Office workers or part-time employees who work indoors at least once a week.
3. Subjects who have a self-awareness of being prone to catching colds.
4. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Key exclusion criteria

1. Subjects who test positive for any one of the following in the preliminary examination: HBs antigen, HCV antibodies, syphilis antibodies, HIV antigens or antibodies.
2. Subjects who plan to receive any type of vaccine between the time of consent acquisition and the end of the study.
3. Subjects with chronic conditions such as chronic rhinitis or asthma, which could be difficult to distinguish from upper respiratory tract infections.
4. Subjects with severe hay fever who cannot restrict medication during the trial period (excluding eye drops and nasal sprays).
5. Subjects who experience abdominal symptoms (such as diarrhea, abdominal pain, bloating) upon consumption of dairy products.
6. Subjects who consume fermented dairy products (yogurt, lactic acid bacteria beverages) or lactobacillus preparations more than twice a week.
7. Subjects who regularly use Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health food (including supplements) more than twice a week, which may potentially affect the study and cannot discontinue them from the time of consent acquisition.
8. Subjects who are taking medications (such as antibiotics, Intestinal preparations, laxatives) more than twice a week, which may potentially affect the trial, and cannot restrict their use during the study period.
9. Subjects who excessive alcohol intake.
10. Subjects who smoke heavily (not less than 21 cigarettes a day)
11. Subjects with having irregular life rhythms, such as extremely irregular eating habits or those working night shifts.
12. Subjects with an exercise routine of more than five times per week, each session lasting more than 30 minutes.
*For reference, exercise is defined as activities corresponding to 7 METs or higher according to the METs table published by the Ministry of Health, Labour and Welfare.

Target sample size

200

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Yakult Central Institute

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.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

2023

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

200

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

2023

Year

11

Month

20

Day

Date of IRB

2023

Year

11

Month

17

Day

Anticipated trial start date

2023

Year

12

Month

03

Day

Last follow-up date

2024

Year

03

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
13. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
14. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
15. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
16. Subjects with allergies to medications and food, especially dairy products.
17. Subjects who donated blood or component (200 mL) within the last 1 months.
18. Subjects who donated his blood (400 mL) within the last 3 months.
19. Subjects who donated her blood (400 mL) within the last 4 months.
20. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study
21. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
22. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Registered date

2023

Year

12

Month

01

Day

Last modified on

2025

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060308