UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Title of the study (Brief title)	Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Region	Japan

Condition
Condition	cedar pollen allergy
Classification by specialty	Clinical immunology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin prick test (positive rate, rash diameter, redness diameter), questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 4 weeks
Interventions/Control_2
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 64 years of age (2) Subjects who are aware of cedar pollen allergy (3) Subjects with positive specific IgE test and skin prick test against cedar antibodies
Key exclusion criteria	(1) Subjects that regularly consume enhanced test food (2) Subjects that regularly consume dietary supplements which may influence immune function (3) Subjects with history of the allergic disease or anaphylactic shock (except for hay fever) (4) Subjects undergoing medical treatment which may influence the outcome of the study (5) Subjects with skin disease or a tattoo on the arm (6) Night and day shift worker or manual laborer (7) Subjects with intensive physical activity (8) Subjects with poor adherence to the measurement procedures (9) Subjects with severe diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) and diseases that may affect the adrenal cortical hormone secretion (10) Subjects potentially allergic to contents in test food (11) Subjects who are judged inappropriate for the study according to the results of screening tests (12) Subjects who intend to become pregnant during the study period or being pregnant or lactating (13) Subjects who have participated in other clinical studies within one month from obtaining informed consent or intend to participate in other clinical studies after obtaining informed consent (14) Subjects who are judged inappropriate for the study according to the results of lifestyle questionnaire (15) Subjects who are judged inappropriate for the study by the physician
Target sample size	10

Research contact person
Name of lead principal investigator	Akihito Tomonaga
Organization	Tana orthopedic surgery
Division name	Orthopedic surgery
Address	15-7, Tana-cho, Aoba-ku, Yokohama-city, Kanagawa
TEL	045-989-2225
Email	soyaku@kaiseikai-net.or.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	KYOWA 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	2018 Year 01 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 19 Day
Anticipated trial start date	2018 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	2017 Year 12 Month 28 Day
Last modified on	2018 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034959