UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030382
Receipt number R000034685
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
Date of disclosure of the study information 2018/01/13
Last modified on 2018/12/26 18:58:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of various symptoms of hay fever

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



Funding Source

Organization

Asahi Calpis Wellness Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name