UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030611 |
|---|---|
| Receipt number | 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 13:12:49 |
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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
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
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034959
