UMIN-CTR Clinical Trial

Public title

Evaluation of improvement of arious symptoms of hay fever by intake of lactic acid bacteria-containing food
Improvement of various symptoms of hay fever

Acronym

Improvement of various symptoms of hay fever

Scientific Title

Evaluation of improvement of arious symptoms of hay fever by intake of lactic acid bacteria-containing food
Improvement of various symptoms of hay fever

Scientific Title:Acronym

Improvement of various symptoms of hay fever

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Improvement of various symptoms of hay fever

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Questionnaire survey about various symptoms of hay fever before ingestion and after the end of ingestion period

Key secondary outcomes

Blood test
Urine recovery (at our laboratory)
Doctor's findings and evaluations
Health diary
Doctor's findings and evaluations (for health diary)
Measurement of blood pressure and pulse

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

Treatment

Type of intervention

Food

Interventions/Control_1

Test food: ingestion of food ontaining lactic acid bacteria
2 tablets/day, 12 weeks

Interventions/Control_2

Placebo: intake of food not ontaining lactic acid bacteria
2 tablets/day, 12 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

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

Japanese males and females aged 20 to 59 years old at the time of acquiring consent

Persons who have been aware of various symptoms of Japanese cedar pollinosis for 2 years or more, or have a history of cedar pollinosis (mild to moderate) for 2 years or more

Persons with symptoms of cedar pollinosis (sneezing, runny nose, stuffy nose, eye itching) in the past 2 years

Persons who do not currently develop cedar pollinosis

Key exclusion criteria

Persons undergoing treatment for perennial rhinitis

Persons undergoing hyposensitization therapy or hospital therapy for hay fever (excluding drug therapy)

Persons who are taking steroids in hay fever drug therapy (excluding other antiallergic drugs and OTC drugs)

Persons who are suffering from specific diseases and are undergoing outpatient medication treatment (excluding hay fever)

Persons who are routinely taking medicines (lactobacillus preparations etc.) that are likely to affect the test results, or taking health foods (supplements that describe effectiveness against hay fever, but not foods such as yoghurt)

During pregnancy or possibly pregnant, and those who are breastfeeding

Persons who are likely to have allergic symptoms due to the test food component

Persons participating in other clinical trials

Persons who have a history of serious liver disorder, renal disorder, heart disease

Persons who have a history of hepatitis or who are currently suffering from hepatitis

Persons with advanced anemia

Persons who are taking antiallergic drugs or being treated for atopic dermatitis, asthma, etc.

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code

Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1590

Email

jimukyoku@mail.souken-r.com

Name of contact person

1st name
Middle name
Last name	Ko MASUDA

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code

Address

3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1555

Homepage URL

Email

k_masuda@mail.souken-r.com

Institute

Shiba Palace Clinic

Institute

Department

Personal name

Organization

Asahi Calpis Wellness 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

01

Month

13

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

11

Month

13

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

13

Day

Last modified on

2018

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034685