UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034239
Receipt number R000039026
Scientific Title Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Date of disclosure of the study information 2018/09/23
Last modified on 2020/03/24 10:50:16

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Basic information

Public title

Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria

Acronym

Inhibition of allergy by intake of lactic acid bacteria

Scientific Title

Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria

Scientific Title:Acronym

Inhibition of allergy by intake of lactic acid bacteria

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Clinical immunology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the anti-allergic effects of lactic acid bacteria on healthy adults who have had allergic symptoms that seems to be caused by cedar pollen

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Symptoms caused by cedar pollen

Key secondary outcomes

Nasal cavity findings, Nasal eosinophil score, Serum cytokine etc.


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

Prevention

Type of intervention

Food

Interventions/Control_1

Lactic acid bacteria, one tablet/day, 8 consecutive weeks

Interventions/Control_2

Placebo, one tablet/day, 8 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Subjects who obtained written consent regarding participation in research
2) Healthy adults aged 20 years or over, 65 years old or younger at the time of consent acquisition
3) Subjects who do not appear symptoms of allergic rhinitis in a period of not scattering cedar pollen, and do not need the medications
4) Subjects who the cedar pollen-specific IgE value is 2 or more
5) Subjects judged as appropriate for the study by the investigator in the medical examination

Key exclusion criteria

1) Pregnant women or women with potential for pregnancy, and women who want pregnancy during this study
2) Lactating women
3) Subjects with severe disease of respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease or those with a past history
4) Subjects who have acute rhinitis, sinusitis, hypertrophic rhinitis
5) Subjects who have bronchial asthma combined
6) Those who are undergoing treatment (sublingual immunotherapy, etc.) that affects the results of the study
7) Subjects receiving treatment for antihistamines, anti-leukotriene drugs, steroids for nasal spray, oral steroids, immunotherapy
8) Subjects with milk allergy
9) Subjects who regularly intake foods rich in lactic acid bacteria (kimchi, pickles, beverages containing lactic acid bacteria, yoghurt, food for specified health uses, foods with function claims, supplements) and pharmaceuticals (Biofermin, etc)
10) Subjects who regularly intake anti-allergic foods
11) Subjects who make a blood donation of 400 ml within 12 weeks before the preliminary medical examination or that of 200 ml within 4weeks before the preliminary medical examination
12) Subjects who are estimated inappropriate to this study by the principal investigator and the principal researcher.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Tadao
Middle name
Last name Enomoto

Organization

NPO Japan Health Promotion Supporting Network

Division name

Not applicable

Zip code

640-8269

Address

TE Build. 5F, 3-68, Komatsubaradori, Wakayama

TEL

073-432-3005

Email

t-enomoto@tempo.ocn.ne.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Saito

Organization

Otsuka Pharmaceutical Co.,Ltd.

Division name

Otsu Nutraceuticals Research Institute

Zip code

520-0002

Address

3-31-13 Saigawa Otsu, Shiga

TEL

077-521-8835

Homepage URL


Email

Saito.Takao@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

NPO Japan Health Promotion Supporting Network

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical corporation Sanyuukai Abe Clinic

Address

Nippori Ekimaechuo Building 5F, 6-60-10, Higashinippori, Arakawa-ku, Tokyo, 116-0014

Tel

03-5810-7808

Email

abecl-rinri@medicos-group.com


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 09 Month 23 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

2018 Year 09 Month 12 Day

Date of IRB

2018 Year 09 Month 19 Day

Anticipated trial start date

2018 Year 09 Month 24 Day

Last follow-up date

2018 Year 12 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 22 Day

Last modified on

2020 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039026


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name