UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025924
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email 214sy01@hosp.go.jp

Sponsor
Institute National Hospital Organization Shimoshizu National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029808

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.