UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025924 |
|---|---|
| Receipt number | R000029808 |
| Scientific Title | Study of beneficial effects of citrus juice fermented with lactic acid bacteria on the symptoms of Japanese cedar pollinosis; a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2018/03/02 12:02:09 |
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Basic information
Public title
Study of beneficial effects of citrus juice fermented with lactic acid bacteria on the symptoms of Japanese cedar pollinosis; a randomized, double-blind, placebo-controlled trial
Acronym
Study of beneficial effects of citrus juice fermented with lactic acid bacteria on the symptoms of Japanese cedar pollinosis
Scientific Title
Study of beneficial effects of citrus juice fermented with lactic acid bacteria on the symptoms of Japanese cedar pollinosis; a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Study of beneficial effects of citrus juice fermented with lactic acid bacteria on the symptoms of Japanese cedar pollinosis
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate effects of citrus juice fermented with lactic acid bacteria on attenuation of the symptoms of Japanese cedar pollinosis in a randomized, double-blind, placebo-controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The symptoms of Japanese cedar pollinosis after starting consumption of test beverage
Key secondary outcomes
Results of blood test / Quality of life(QOL)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking 125ml of citrus juice fermented with lactic acid bacteria every day for 8 weeks during pollen scattering season.
Interventions/Control_2
Taking 125ml of unfermented citrus juice (placebo) every day for 8 weeks during pollen scattering season.
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
The subjects who experienced the symptoms of Japanese cedar pollinosis in the last pollen scattering season and whose Japanese cedar pollen-specific IgE levels are positive.
Key exclusion criteria
1)Those who has allergy to the test beverage and citrus
2)Pregnant woman and those at risk of pregnancy
3)Woman who are planning pregnancy
4)Lactating woman
5)The subject who are judged inappropriate for the study by the doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Suzuki |
Organization
National Hospital Organization
Shimoshizu National Hospital
Division name
Department of Pediatrics
Zip code
Address
934-5,Shikawatashi,Yotsukaido,Chiba
TEL
043-422-2511
214sy01@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Suzuki |
Organization
National Hospital Organization Shimoshizu National Hospital
Division name
Department of Pediatrics
Zip code
Address
934-5,Shikawatashi,Yotsukaido,Chiba
TEL
043-422-2511
Homepage URL
214sy01@hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shimoshizu National Hospital
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
| 2017 | Year | 01 | Month | 31 | 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
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
