UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shuichi Suzuki
Organization	National Hospital Organization Shimoshizu National Hospital
Division name	Department of Pediatrics
Address	934-5,Shikawatashi,Yotsukaido,Chiba
TEL	043-422-2511
Email	214sy01@hosp.go.jp

Public contact
Name of contact person	Shuichi Suzuki
Organization	National Hospital Organization Shimoshizu National Hospital
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029808