UMIN-CTR Clinical Trial

Public title

The effects of ingestion of the beverage containing Lactobacillus on upper respiratory tract symptoms (URTI) symptoms and parameters of innate immunity in healthy adults

Acronym

The effects of ingestion of the beverage containing Lactobacillus on URTI and innate immunity in healthy adults

Scientific Title

The effects of ingestion of the beverage containing Lactobacillus on upper respiratory tract symptoms (URTI) symptoms and parameters of innate immunity in healthy adults

Scientific Title:Acronym

The effects of ingestion of the beverage containing Lactobacillus on URTI and innate immunity in healthy adults

Region

Japan

Condition

Healthy Adult

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine the effect of the drinks containing Lactobacillus on subjective URTI symptom, immune parameters (NK cell activity and salivary IgA) and to assess the safety of the drink. in healthy subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Improvement of subjective URTI symptom during the study period.

Key secondary outcomes

･Improvement of salivary s-Ig A during the study period.
･Improvement of NK cell activity during the study period.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

8 weeks
200ml per day
Once a day
Administer the test drink containing Lactobacillus powder to subjects.

Interventions/Control_2

8 weeks
200ml per day
Once a day
Administer placebo to subjects within 8 weeks.
The composition of the test and placebo drink were the same, except that the test drink contained Lactobacillus powder.

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

-Japanese males and females aged 20-65
-Those who are aware of their predisposition to the common cold

Key exclusion criteria

(1) Those who are absence of subjective symptoms of URTIs during the two preceding winters.
(2) Those who routinely use food or medicine containing of lactobacillus more than 3 times a week(3) Those who take a medicine which may influence the immunity.
(4) Those who routinely take dietary supplements which may influence immune function.
(5) Those who has vaccinations within four weeks of enrollment.
(6)Those who has history of the allergic disease.
(7)Those who are under medication which may influence the outcome of the study.
(8) Those 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) Those who has oral or dental problems with bleeding.
(10) Night and day shift worker or manual laborer.
(11) Those who has routinely carries out an intense activity.
(12) Those who cannot carry out a procedure of various inspection by the rule during the study period.
(13) Those who has a disease under treatment or are diagnosed to that medical treatment are necessary by the physicians.
(14)Those who are diagnosed serious medical problems by physicians.
(15) Those who has under treatment or a history of serious disease and disease to affect the adrenal cortical hormone secretion.
(16)Those who may have allergy to ingredients of the test material.
(17)Those who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(18)Those who are pregnant, likely to be pregnant, or breast-feeding.
(19) Those who have participated in other clinical study within the last 1 month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(20) Those who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(21) Those who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Jiro Saito

Organization

Medical Station Clinic

Division name

Chair

Zip code

Address

3-12-8 takaban, meguro-ku, Tokyo, Japan

TEL

03-6452-2712

Email

info@med-station.jp

Name of contact person

1st name
Middle name
Last name	Hiroyasu Shimada

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

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

Asahi Group Holdings,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

メディカルステーションクリニック（東京都）
医療法人社団生光会新宿追分クリニック(東京都)

Date of disclosure of the study information

2017

Year

04

Month

01

Day

URL releasing protocol

https://www.pieronline.jp/content/article/0386-3603/45100/1687

Publication of results

Published

URL related to results and publications

https://www.pieronline.jp/content/article/0386-3603/45100/1687

Number of participants that the trial has enrolled

129

Results

Throat and cough discomfort scores were significantly elevated in the placebo group but not in the Lactobacillus acidophilus L-92 group. A significant difference in baseline changes in throat discomfort scores was also observed between the placebo and L-92 groups. The change in NK cell activity in peripheral blood was significantly higher in the L-92 group compared with the control throughout the study period. The other results were published in Jpn Pharmacol Ther (vol. 45 no. 10, 1687 - 1695 (2017)).

Results date posted

2023

Year

08

Month

29

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Healthy male and female aged 20 to under 65 years old.

Participant flow

Of the 162 patients, 28 did not meet eligibility criteria and 5 withdrew their consent, but were randomly assigned to the two groups. All 126 patients completed the entire examination, excluding those who dropped out during the course of the study.

Adverse events

No adverse events have been observed.

Outcome measures

Subjective upper respiratory tract symptoms and immune parameters

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

10

Month

22

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

05

Day

Last follow-up date

2016

Year

02

Month

26

Day

Date of closure to data entry

2016

Year

03

Month

18

Day

Date trial data considered complete

2016

Year

03

Month

18

Day

Date analysis concluded

2016

Year

06

Month

09

Day

Other related information

Registered date

2017

Year

01

Month

25

Day

Last modified on

2023

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029712