UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for allergic disease.a randomized, placebo controlled, parallel-group trial
Title of the study (Brief title)	PRT-LB-MF-AR-LBSCR-01-01
Region	Japan

Condition
Condition	Allergic rhinitis (hay fever) Allergic conjunctivitis Atopic dermatitis Bronchial asthma
Classification by specialty	Medicine in general Clinical immunology Chest surgery Ophthalmology Dermatology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of the food consisting of LB-Scr and ECM-E(cockscomb extract containing hyaluronic acid) for allergic disease are verified. These are evaluated for a placebo. The value of Ige and IL-12 level are investigated as items of examination. These are measured 0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The efficacy of the food consisting of LB-Scr and ECM-E(cockscomb extract containing hyaluronic acid) for allergic disease are verified. These are evaluated for a placebo. The value of Ige and IL-12 level are investigated as items of examination. These are measured 0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start.
Key secondary outcomes	A general blood test, biochemical examination, urinalysis, insulin hyaluronic acid, serotonin and changes of skin condition observed by Robo Skin Analyzer RSA 50 made by Inforward,inc and other usefulness and safeties such as side effects are verified. (A general blood test, a biochemical examination, urinalysis, and skin condition) First day, 28th day, 56th day, 84th days 112nd day, 140th day and 168th day after the first day of ingestion. (Serotonin) First day, 56th day, 112nd day and 168th day after the first day of ingestion.

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	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine Food
Interventions/Control_1	LB-Scr and ECM-E Ingestion period:168 plus or minus 7day Intake:1800mg/time-Time before a meal 3 times The number of times of a visit to the hospital: First day,28th day, 56th day, 84th days 112th day and 168th day
Interventions/Control_2	Placebo Ingestion period:168 plus or minus 7day Intake:1800mg/time-Time before a meal 3 times The number of times of a visit to the hospital: First day,28th day, 56th day, 84th days 112th day and 168th day
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	13 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects for the experiment must be apatient who meets all the following standards. 1)The patient who is Japanese and is between 13 and 45 years old at the time of Informed Consent (Sex is not asked). 2)The patient who is taking medical treatment as a visitor or wishes to take medical treatment as a visitor (Only visitors). 3)the patient who has been diagnosed with one or more chronic allergic disease of the following through a year or in a certain season and is receiving medical treatment every time when the patient get the allergic disease. Allergic rhinitis (hay fever) Allergic conjunctivitis Atopic dermatitis Bronchial asthma 4)The patient who is taking medicine for allergic disease or can be regarded as the person who get prescription by medical institution from its chart. 5) Patients who can get written informed consent before enrolling the study. However, the consent from a legal representative person must be obtained if a subject is underage.
Key exclusion criteria	The patient who corresponds to either of the followings can't participate in this clinical study. 1)The patient who changed diabetic medicine in the observation term till the first day of ingestion 2)The patient who has a food allergy of mushrooms (fungi) and the patient who has a chronic food allergy 3)The patient who has a food allergy in chicken and a chicken egg or a chronic food allergy 4)The patient who has a tattoo. 5)The patient who has Mucopolysaccharidosis 6)The patient who has the past of myocardial infarction 7)The patient who has the past of a coronary-arterial-blood line reconstruction way (PCI or CABG) 8)The patient who merges unstable angina pectoris 9)The patient who has the past of cerebrovascular disorder (except for asymptomatic lacunar infarction) 10)The patient who has the past of heart failure 11)The patient who has critical liver disease 12)The patient who has critical renal disease 13)The woman who is pregnant or the woman who wishes to become pregnant during exam time. 14)The woman who is under breast-feeding 15)The patient who has participated in other clinical study or received medical treatment of new drug within 12 weeks before the ingestion start of test meal. 16)The patient who is taking medical treatment of psychiatric disorder or the patient who is judged by a doctor to need medical treatment of psychiatric disorder. 17)In addition, the person who identified as improper by the investigator or subinvestigators.
Target sample size	51

Research contact person
Name of lead principal investigator	Shigehiro Kure
Organization	Sanbongi Clinic
Division name	Clinic Director
Address	2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL	0561-56-4532
Email	shigehiro_kure@yahoo.co.jp

Public contact
Name of contact person	Hiromichi Hayashi
Organization	Medical Fusion Co.,Ltd.
Division name	Clinical Development Division
Address	Nagoya Life Science Incubator,2-22-8,Chikusa,Chikusa-ku,Nagoya,Aichi,464-0858,Japan
TEL	052-745-3300
Homepage URL
Email	info@m-fusion.co.jp

Sponsor
Institute	LABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
Institute
Department

Funding Source
Organization	LABOAG Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1,Medical institutions conduct clinical research MEDOC Medical Dock&Clinic 2,CRO Medical Fusion Co.,Ltd. 3,OEM ADAPTGEN PHARMACEUTICAL CO.,LTD.
Name of secondary funｄer(s)	Shachihata Inc,. Provision of "PC approval"management software and electronic seal

Secondary IDs
Secondary IDs	YES
Study ID_1	JMA-IIA00105
Org. issuing International ID_1	JMACCT CTR
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人メドック健康クリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 18 Day
Anticipated trial start date	2013 Year 01 Month 15 Day
Last follow-up date	2013 Year 09 Month 26 Day
Date of closure to data entry	2013 Year 11 Month 30 Day
Date trial data considered complete	2013 Year 12 Month 09 Day
Date analysis concluded	2014 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Chiyo foods Co.,Ltd. Chiyo Nakata URL : http://www.khaos.co.jp/ (Audit the implementation date) IRB CRO:Medical institution July 30 2013 CRO:IRB July 31 2013

Management information
Registered date	2012 Year 12 Month 13 Day
Last modified on	2017 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010799