Unique ID issued by UMIN | UMIN000034280 |
---|---|
Receipt number | R000039074 |
Scientific Title | Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration. |
Date of disclosure of the study information | 2018/09/26 |
Last modified on | 2019/04/23 13:17:27 |
Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
Long-term administration of the transgenic rice containing peptides from Japanese cedar pollen allergens and elucidation of the mechanism of oral tolerance induction.
Efficacy
Subjective symptoms
-Scoring of allergy diaries between placebo group and transgenic rice group are compared
1.Surveys on lifestyles
2.JRQLQ
3.Intranasal observation with rhinoscopy
4.Intradermal reaction, number of nasal eosinophil, total serum IgE and cedar pollen-specific IgE
5.Immunological test:Evaluation of T-cell responses to 7crp, Cry j 1 and cry j 2.
6.Examination of height, weight, BMI,body temperature,blood pressure and pulse count
7.Safety (adverse events)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Evaluation of the efficacy of oral administration group of 20g of transgenic rice for 24 weeks
Evaluation of the efficacy of oral administration group of 5g of transgenic rice for 24 weeks
Evaluation of the efficacy of oral administration group of 50g of placebo rice for 24 weeks
20 | years-old | <= |
70 | years-old | > |
Male and Female
1) Adult aged over 20years old and under 70years old and lives or works near The Jikei University School of Medicine.
2) A person who has allergic symptoms such as sneezing, running nose, and nasal obstruction.
3) A person who gives a positive result in provocative test and intradermal test (please refer to appendix for an assessment procedures)
4) Cedar pollen allergen-specific IgE antibody values over Class II.
5) Cypress specific IgE antibody values under Class IV.
6) Stimulation index of T-cell response to allergens over 2.0.
1) A person who is allergic to Rice or has a history of Rice allergy.
2) A person who shows House dust specific IgE antibody valued over Class V, and has chronic rhinitis
3) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation.
4) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation.
5) A person who has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant.
6) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder.
7) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder.
8) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia.
9) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia.
10) A person who is complecated by asthma.
11) A person who has laboratory abnormalities in the pre-clinical test that trial investigator has assessed as mismatched participant.
12) A person already in another clinical test when this clinical test begins.
13) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test.
14) A person whom trial investigator has asessed as mismatched participant.
45
1st name | |
Middle name | |
Last name | Daiya Asaka |
The Jikei University School of Medicine
Department of Otorhinolaryngology
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461
03-3433-1111
asaka@jikei.ac.jp
1st name | |
Middle name | |
Last name | Daiya Asaka |
The Jikei University School of Medicine
Department of Otorhinolaryngology
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461
03-3433-1111
asaka@jikei.ac.jp
The Jikei University School of Medicine
The Jikei University School of Medicine
Other
NO
東京慈恵会医科大学附属病院
2018 | Year | 09 | Month | 26 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 18 | Day |
2016 | Year | 10 | Month | 12 | Day |
2016 | Year | 11 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 26 | Day |
2019 | Year | 04 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039074