Unique ID issued by UMIN | UMIN000020050 |
---|---|
Receipt number | R000023154 |
Scientific Title | Efficacy of 1-kestose on allergic symptoms caused by Japanese cedar pollinosis: randomised double-blind trial |
Date of disclosure of the study information | 2015/12/04 |
Last modified on | 2019/06/27 14:25:59 |
Efficacy of 1-kestose on allergic symptoms caused by Japanese cedar
pollinosis: randomised double-blind trial
Efficacy of 1-kestose on allergic symptoms caused by Japanese cedar
pollinosis
Efficacy of 1-kestose on allergic symptoms caused by Japanese cedar
pollinosis: randomised double-blind trial
Efficacy of 1-kestose on allergic symptoms caused by Japanese cedar
pollinosis
Japan |
Japanese cedar pollinosis
Clinical immunology |
Others
NO
To evaluate whether intake of 1-kestose,
a prebiotics, may ameliorate allergic symptoms caused by Japanese cedar pollinosis
Safety,Efficacy
Confirmatory
Others
Phase II
Change of symptom score (rhinorrhea, sneezing, nasal obstruction, nose itching, eye itching, lacrimation; severity 0~4)
QOL score, Drug usage score, Symptom+drug usage score, Intestinal flora, Adverse events
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Food |
Intake of 5g 1-kestose for 56 days in the morning every day
As placebo, intale of maltose for 56 days in the morning every day
20 | years-old | <= |
Not applicable |
Male and Female
1. Assertion of document informed consent
2. Persons who had previously presented with allergic symptoms such as sneezing, rhinorrhea or nasl obstruction in association with exposure of Japanese cedar pollen
3. Persons who live in or within 50 Km apart from Chita City.
1. Due to chronic diseases or difficulty in describing their symptom scores in the symptom dairy or qestionnaire, persons are not appropriate for the entry by doctors' evaluation.
2. Persons who take functional foods including probiotics or prebiotics in order to suppress allerguc symotoms
3. Persons who receive or will receive immunotherapy against Japanese cedar pollinosis
4. Persons who continuously take anti bacterial drug
5. Pregnant, lactating women or women who are planning a pregnancy
6. Persons who are enrolled into other clinical trials
32
1st name | Toshio |
Middle name | |
Last name | Tanaka |
Department of Clinical Application of Biologics
Osaka University Graduate School of Medicine
565-0871
2-2 Suita City, Osaka 5656-0871, Japan
06-6210-8366
ttanak@imed3.med.osaka-u.ac.jp
1st name | Toshio |
Middle name | |
Last name | Tanaka |
Department of Clinical Application of Biologics
Osaka University Graduate School of Medicine
565-0871
2-2 Suita City, Osaka 5656-0871, Japan
06-6210-8366
ttanak@imed3.med.osaka-u.ac.jp
Department of Clinical Application of Biologics, Osaka University Graduate School of Medicie
B Food SCIENCE
Profit organization
Japan
Clinical Research Center of Osaka Yniversity Hospital
2-2 Yamada-oka Suita City Osaka 565-0871
06-6210-8090
rinri@hp-crc.med.osaka-u.ac.jp
NO
2015 | Year | 12 | Month | 04 | Day |
Unpublished
Completed
2015 | Year | 10 | Month | 26 | Day |
2015 | Year | 12 | Month | 03 | Day |
2015 | Year | 12 | Month | 25 | Day |
2016 | Year | 03 | Month | 27 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 09 | Month | 30 | Day |
2015 | Year | 12 | Month | 03 | Day |
2019 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023154
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