UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027791 |
|---|---|
| Receipt number | R000031843 |
| Scientific Title | A study for the effects of ingestion of yogurt in adults with discomfort of eyes and nose :A randomized, double-blind, placebo controlled trial |
| Date of disclosure of the study information | 2018/12/23 |
| Last modified on | 2019/11/27 16:50:30 |
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Basic information
Public title
A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose :A randomized, double-blind, placebo controlled trial
Acronym
A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose
Scientific Title
A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose :A randomized, double-blind, placebo controlled trial
Scientific Title:Acronym
A study for the effects of ingestion of
yogurt in adults with discomfort of eyes and nose
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of ingestion of yogurt on the subjective evaluation of the discomfort of eyes and nose, and blood index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire of discomfort of eyes and nose,Diary.
Evaluate at points of 12-week and 4-week, 8-week
Key secondary outcomes
Specific IgE(RAST), IFN-Gamma, IL-13, Total IgE(RIST)
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 yogurt drink containing lactic acid bacteria LH strain for 12 consecutive weeks
Interventions/Control_2
Ingestion of yogurt drink without lactic acid bacteria LH strain for 12 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)Subjects aged from 20 to 64 years old
(2)Subjects with discomfort of eyes and nose(sneeze,runny nose, nasal)
(3)Subjects positive for specific IgE(RAST)against house dust or mite.
(4)Subjects who are judged as healthy adult for the study by the investigator
Key exclusion criteria
(1)Subjects who routinely take foods or medicines containing of lactic acid bacteria.
(2)Subjects who routinely take foods or medicines affecting the test result
(3)Subjects who have history of
regular visits of otorhinolaryngology or planned to clinic visits
(4)Subjects who has received a diagnosis of seasonal allergic rhinitis (pollen allergy)
(5)Subjects with acute rhinitis, sinusitis or hypertrophic rhinitis
(6)Subjects with bronchial asthma
(7)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(8)Subjects who are under medication(e.g., hyposensitization)which may influence the outcome of the study
(9)Subjects with allergies to the test food in the study
(10)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function
(11)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(12)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(13)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
(14)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(15)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(16)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujta |
Organization
MEGMILK SNOW BRAND Co.,Ltd.
Division name
Milk Science Research Institute. Food Function Laboratory
Zip code
Address
1-1-2 Minamidai,Kawagoe,Saitama,Japan
TEL
049-242-8111
tfujita@meg-snow.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Goto |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
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 | 12 | 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
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031843
