UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051546 |
|---|---|
| Receipt number | R000058817 |
| Scientific Title | Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food |
| Date of disclosure of the study information | 2024/12/26 |
| Last modified on | 2025/01/16 15:53:42 |
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Basic information
Public title
Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food
Acronym
Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food
Scientific Title
Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food
Scientific Title:Acronym
Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of cedar pollen on nose and eye discomfort when the test food is continuously ingested for 8 weeks will be verified by comparing it with the control food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Record during pollen exposure (before entering ~ leaving exposure room)
Subjective ocular and nasal discomfortable and disruption of daily routines (the number of sneezes , nose blowing, and Visual analogue scale(nasal blockage, nasal itching, disturbance of daily living [Overall behavior in the room and when using a smartphone/tablet], eye itching, watery eyes, throat symptoms, and sleepiness)
Key secondary outcomes
Record after pollen exposure (the first day of exposure and continuing for 5 successive days after exposure)
Subjective ocular and nasal discomfortable and disruption of daily routines (the number of sneezes, nose blowing, and Visual analogue scale(nasal blockage, nasal itching, disturbance of daily living [Overall behavior in the room and when using a smartphone/tablet], eye itching, watery eyes, throat symptoms, and sleepiness)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 consecutive weeks
Interventions/Control_2
Intake of control food for 8 consecutive weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Subjects who obtained the consent about participation in the study
(2)males and females from 20 to under 65 years of age at the time obtaining consent
(3)Subjects who complained of eye and nasal discomfort at Japanese cedar pollen season for the last 2 years
(4)Subjects with CAP-RAST against JCP >= class 2
Key exclusion criteria
(1)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(2)Subjects who get the vaccine last week before the Japanese cedar exposure and 4 days after the exposure
(3)Subjects who are treated with allergen immunotherapy (e.g. SLIT, SCIT etc.) and nonspecific desensitization therapy or surgery for allergic rhinitis (e.g. laser surgery etc.) within the 3 year prior to the time of obtaining consent about participation in the study or plan them during the study
(4)Subjects who have acute rhinitis, nasal sinuses, hypertrophic rhinitis, or perennial allergy
(5)Subjects who are taking antiallergic drug (except from ointment)
(6)Subjects who received steroid medication (e.g. Kenacort-A) within the 6 months prior to the time of obtaining consent
(7)Subjects who having a habit of drinking coffee, Pu-erh tea or Awa bancha tea more than 5 days a week (more than 100mL a day)
(8)Subjects who are judged to be unsuitable based on the results of clinical examinations
(9)Subjects who having food allergy
(10)Subjects who are pregnant, and subjects who plan, may or wish to become pregnant during the study period
(11)Subjects who were breastfeeding
(12)Subjects who smoke excessively (more than 21 cigarettes a day)
(13)Subjects who regularly consume large amount of alcohol (having >= 60g/day of alcohol more than 5 days a week )
(14)Subjects who have participated in other clinical study within the last three months at the time of obtaining consent
(15)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Sanbongi |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji-shi, Tokyo
TEL
0426325847
chiaki.sanbongi@meiji.com
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Tsuji |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center, Foods Department
Zip code
162-0821
Address
Kagurazaka AK Building, 1-8 Tsukudocho, Shinjuku-ku, Tokyo, Japan
TEL
0356579130
Homepage URL
tsuji.shinsuke472@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
0364522712
nakagawa.akiko297@eps.co.jp
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
| 2024 | Year | 12 | Month | 26 | 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
100
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
| 2023 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 05 | Month | 07 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058817
