UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
Title of the study (Brief title)	A clinical trial to evaluate the effect of improving allergy-like symptoms
Region	Japan

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

Objectives
Narrative objectives1	This trial aims to evaluate the effect of ingestion of the test foods on allergy-like symptoms such as rhinitis to subjects feeling these symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	[JRQLQ] nasal symptom ophthalmic symptom QOL question
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test material: Shiitake mycelium extract powder Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Interventions/Control_2	Duration: 8 weeks Test material: Shiitake mycelium extract powder and Bifidobacterium BR108 Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Interventions/Control_3	Duration: 8 weeks Test material: Placebo Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults, who suffer from allergy-like symptoms
Key exclusion criteria	a.Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction b.Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease c.Persons who take medicines, herbal medicines, supplements related to test food. d.Persons who take foods/drinks expected to be related with gut health, such as Food for Specified Health Uses (FOSHU), yogurt and, lactic fermenting beverage e.Persons who are allergic to medicines, or products related to the test material of this trial f. Persons who have been judged as pollinosis by doctors g.Pregnant women, lactating women, or women who want to get pregnant during the trial period h.Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial i.Persons who are judged not suitable to participate in this trial by physician
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization	Amino Up Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
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	2015 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 01 Month 16 Day
Last follow-up date	2015 Year 05 Month 01 Day
Date of closure to data entry	2015 Year 05 Month 15 Day
Date trial data considered complete	2015 Year 05 Month 20 Day
Date analysis concluded	2015 Year 05 Month 29 Day

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

Management information
Registered date	2015 Year 01 Month 15 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018822