UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy for Japanese cedar pollinosis (Randomized placebo controlled double blind clinical study)
Title of the study (Brief title)	Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy
Region	Japan

Condition
Condition	Japanese cedar pollinosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine an additive effect of the citrous juice fermented with lactic bacteria (YIT0132) to sublingual immunotherapy for Japanese cedar pollinosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the total nosal symptom medication score converted from a nasal allergy diary in peak of cedar pollen scattering
Key secondary outcomes

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 bacteria (YIT0132) every day for 3 month around cedar pollen scattering period.
Interventions/Control_2	Taking 125ml of placebo every day for 3 month around cedar pollen scattering period.
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	Patients with Japanese cedar pollinosis who is being treated with sublingual immunotherapy
Key exclusion criteria	1) Allergy to the intervention drink or citrus juice 2) Diabetes mellitus (HbA1c more than 6.0) 3) Pregnant women and those at risk of pregnancy 4) Women who are planning pregnancy 5) Lactating woman 6) Patients treated with anti-allergic drugs within 2 week of screening 7) The patients who the doctor judged inappropriate for the study 8) Severe asthma 9) Malignant disease or immune disorder
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Chiba University Graduate School
Division name	Department of Otorhinolaryngology
Address	1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL	043-222-7171
Email	yokamoto@faculty.chiba-u.jp

Public contact
Name of contact person	Syuji Yonekura
Organization	Chiba University Graduate School
Division name	Department of Otorhinolaryngology
Address	1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL	043-222-7171
Homepage URL
Email	syonekura@faculty.chiba-u.jp

Sponsor
Institute	Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 01 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 01 Month 04 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	2016 Year 01 Month 03 Day
Last modified on	2018 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023584