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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037571
Receipt No. 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 2020/02/26

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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
Institute TTC Co., Ltd
Institute
Department

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 No longer recruiting
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
2020 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.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


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