UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780
Title of the study (Brief title)	Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate anti-allergic effects of daily ingestion of Lactococcus lactis subsp. cremoris YRC3780 for 12 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Total nasal symptom score, total ocular symptom score (Measurement time: Before starting the ingestion of test meals. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 weeks after the ingestion of test meals. And 1 and 2 weeks after the end of ingestion of test meals.)
Key secondary outcomes	Symptom score (sneezing, runny nose, stuffy nose, itchy eyes, watery eyes, throat symptoms and inconvenience for daily life), total symptom score, medication score, symptom-medication score (SMS), nasal SMS, ocular SMS, total IgE, white birch pollen-specific IgE, Th1/Th2 cytokine (IFN-gamma, IL-10), TARC, eosinophil count and WBC differential count

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of capsules containing high-dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.
Interventions/Control_2	Ingestion of capsules containing middle-dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.
Interventions/Control_3	Ingestion of capsules containing low- dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.
Interventions/Control_4	Ingestion of placebo capsules daily for 12 weeks.
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	1. Subjects suffering from nasal or ocular discomfort caused by white birch pollen. 2. Subjects who were positive for skin prick test to white birch pollen. 3. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria	1. Subjects who have a past history of serious allergic reactions (anaphylaxis, etc.). 2. Subjects with acute rhinitis, sinusitis, nasal polyps, hypertrophic rhinitis and/or severely deviated nasal septum, etc. 3. Subjects with bronchial asthma. 4. Subject who are under immunotherapy such as specific desensitization therapy. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 6. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with abnormal blood pressure or hematological data. 8. Subjects with serious anemia. 9. Pre- or post-menopausal women with complaints of obvious physical changes. 10. Subjects with a history of allergy to medicine and/or food (especially milk and corn). 11. Subjects who regularly take drugs which may affect evaluation of the current study (antihistamines, anti-allergic drugs, steroids, vasoconstrictors, anti-inflammatory drugs, anti-rheumatic drugs, antibiotics, immunosuppressive drugs and/or lactobacillus preparation, etc.). 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 13. Subjects who donated either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 14. Pregnant or lactating women or women expect to be pregnant during the study. 15. Subjects who participate in other clinical trials within the last one month prior to this study. 16. Any other medical reasons judged by the principal investigator.
Target sample size	96

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	Yotsuba Milk Products Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 02 Month 26 Day
Last follow-up date	2016 Year 07 Month 05 Day
Date of closure to data entry	2016 Year 07 Month 26 Day
Date trial data considered complete	2016 Year 08 Month 02 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 26 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024463