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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030611
Receipt No. R000034959
Scientific Title Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Date of disclosure of the study information 2018/01/03
Last modified on 2018/03/14

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Basic information
Public title Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Acronym Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Scientific Title Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Scientific Title:Acronym 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
1st name
Middle name
Last name Akihito Tomonaga
Organization Tana orthopedic surgery
Division name Orthopedic surgery
Zip code
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
1st name
Middle name
Last name Takashi Nakagawa
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 12 Month 19 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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