UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041755 |
|---|---|
| Receipt number | R000047659 |
| Scientific Title | The effect of food containing lactic acid bacteria on nasal and ocular symptoms. |
| Date of disclosure of the study information | 2020/09/11 |
| Last modified on | 2021/04/01 14:44:51 |
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Basic information
Public title
The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Acronym
The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Scientific Title
The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Scientific Title:Acronym
The effect of food containing lactic acid bacteria on nasal and ocular symptoms.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on nasal and ocular symptoms associated with mites and house dust of intake of food containing lactic acid bacteria for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) QOL questionnaire
(2) Diary of discomfort of eyes and nose
Key secondary outcomes
(1) Specific IgE (house dust and mites)
(2) Salivary sIgA concentration, salivary sIgA secretion rate
(3) Medical examination for check subjects nasal condition
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 the test product for 8 consecutive weeks.
Interventions/Control_2
Ingestion of the placebo 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 have frequently presence of nasal discomfort (e.g. sneeze, runny nose, stuffy nose, etc.)
(3)Subjects who have positive for specific IgE against house dust or mites
(4)Subjects who are judged as healthy person or person with mild symptoms by the investigator
(5)More than half of the whole subjects will be selected from healthy person (not using antiallergic drug).
Key exclusion criteria
(1) Subjects who are constantly using drugs or health food affecting nasal and ocular symptoms
(2) Subjects who frequently visit a otorhinology
(3) Subjects who have severe nasal symptoms
(4) Subjects who are complicated by bronchial asthma
(5) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, or metabolic disease)
(6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(7) Subjects who are under medication which may influence the outcome of the study (e.g. specific desensitization therapy)
(8) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care
(9) Subjects who have oral or dental problems with bleeding or develops the trouble at least once a week
(10) Subjects who bleed their teeth at least once a week when brush
(11) Night and day shift worker or manual laborer
(12) Subjects who are habitually vigorous exercise (include professional athlete)
(13) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period
(14) Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function.
(15) Subjects having possibilities for emerging allergy related to the study
(16) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(17) Subjects who have participated in other clinical studies
(18) Subjects who intend to become pregnant or lactating
(19) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(20) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Uchida |
Organization
Yotsuba Milk Products Co., Ltd.
Division name
Reserch Division R&D Center
Zip code
061-1264
Address
465-1, Wattsu, Kitahiroshima-shi, Hokkaido
TEL
011-377-5561
uchida_k@yotsuba.co.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Furuhata |
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
t.furuhata@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Yotsuba Milk Products 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6453-2712
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 | 09 | Month | 11 | 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
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047659
