UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037571
Receipt number R000042833
Scientific Title A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
Date of disclosure of the study information 2020/11/15
Last modified on 2023/06/07 10:39:32

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Basic information

Public title

A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.

Acronym

A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.

Scientific Title

A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.

Scientific Title:Acronym

A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine the effect of food containing lactic acid bacteria on relief from ocular and nasal discomfort for 8 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subject's nasal or ocular symptom in an environmental exposure unit(EEU).
(the number of sneezes and nose blowing, eye itching, watery eyes)

Key secondary outcomes

1.Visual analog scale(EEU)
(nasal blockage, nasal itching, throat symptoms, sleepiness, disturbance of daily living)
2.Visual analog scale(after exposure Japanese cedar pollen)
(the number of sneezes and nose blowing, nasal blockage, nasal itching, eye itching, watery eyes, throat symptoms, sleepiness, disturbance of daily living)
3.QOL questionnaire, diagnosis subject's noses, eosinophil of nasal mucus and skin questionnaire.


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

Ingestion of food containing lactic acid bacteria for 8 consecutive weeks

Interventions/Control_2

Ingestion of placebo without lactic acid bacteria for 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Males and females from 20 to 64 years of age.
(2)Subjects who complained of eye and nasal discomfort and judged tested positive for Japanese cedar pollen specific IgE.
(3)Subjects who are judged as suitable for the study by the investigator.
(4)Subjects who obtained the consent about participation in the study.
(5)Subjects who do not take antiallergic drug account for more than half of whole.

Key exclusion criteria

(1)Subjects who routinely take food or medicine containing lactic acid bacteria or natto bacteria.
(2)Subjects who have severe nasal and eye symptoms affecting judgement of discomfort.
(3)Subjects who routinely take medicines affecting the test result.
(4)Subjects who are under medication (specific desensitization therapy) which may influence the outcome of the study.
(5)Subjects who are engaged in drive a car or operate a hazardous machine.
(6)Subjects judged as unsuitable for the stuzy by the investigator for laboratory evidence or cardiopulmonary function.
(7)Subjects who have a disease requiring regular medication or a history of serious disease for which medication was required.
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(9)Subjects who are liable to cause an allergy related to the study.
(10)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(11)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(13)Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yuhi
Middle name
Last name Saito

Organization

KAMEDA SEIKA Co., Ltd.

Division name

Rice Research Center

Zip code

950-0198

Address

3-1-1, Kameda-KogyoDanchi, Konan-ku, Niigata-shi, Niigata

TEL

025-382-8879

Email

yuuhi_saitou@sk.kameda.co.jp


Public contact

Name of contact person

1st name Chiharu
Middle name
Last name Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

c.goto@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

KAMEDA SEIKA 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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.jp


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

2020 Year 11 Month 15 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

2019 Year 07 Month 25 Day

Date of IRB

2019 Year 07 Month 25 Day

Anticipated trial start date

2019 Year 08 Month 03 Day

Last follow-up date

2019 Year 11 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 01 Day

Last modified on

2023 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name