Unique ID issued by UMIN | UMIN000036317 |
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Receipt number | R000041189 |
Scientific Title | Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status |
Date of disclosure of the study information | 2019/03/28 |
Last modified on | 2022/03/31 00:39:17 |
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Japan |
Healthy volunteers
Adult |
Others
NO
To evaluate the effect of powdered plant-derived lactic acid bacterium (Lactobacillus paracasei IJH-SONE68)-fermented fruit juice on perennial allergy state in subjects with allergic conditions.
Efficacy
Confirmatory
Pragmatic
Not applicable
Changes from baseline of averaged self evaluation score about allergic conditions and VAS score in daily life difficulty.
These are measured at every 4 weeks interval until week 12.
Changes from baseline of averaged total serum IgE and semi-quantitative specific IgE (for house dust 1, house dust 2, allergenic Poaceae, wild weeds, animal dandruff, and fungi).
These are also measured at every 4 weeks interval until week 12.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
Central registration
2
Prevention
Food |
Subjects receive 4 capsules (1000 mg) / day containing IJH-SONE68-fermented pineapple juice powder (sterilized) for 12 weeks.
Subjects receive 4 placebo capsules (1000 mg) / day containing dextrin powder for 12 weeks.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
Subjects
1) who feel allergic conditions, such as sneeze, nasal mucus, stuffy nose, itchiness of eyes, teary eyes, and dull headache.
2) whose self evaluation score is greater than or equal to 8 and lesser than or equal to 20.
3) whose VAS score is greater than or equal to 40.
1) Allergy to pineapple
2) Taking drugs for chronic disease
3) In pregnancy or nursing a child
4) Taking functional food that may affect the allergic conditions
5) Participation in any clinical trial with in 90 days of the commencement of the trial
100
1st name | Masafumi |
Middle name | |
Last name | Noda |
Hiroshima University, Graduate School of Biomedical & Health Sciences
Probiotic Science for Preventive Medicine
734-8553
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
082-257-5288
bel@hiroshima-u.ac.jp
1st name | Masafumi |
Middle name | |
Last name | Noda |
Hiroshima University, Graduate School of Biomedical & Health Sciences
Probiotic Science for Preventive Medicine
734-8553
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
082-257-5288
bel@hiroshima-u.ac.jp
Hiroshima University
Asahi Kohsan Co., Ltd.
Profit organization
Ethics committee of Hiroshima University
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
082-257-5805
kasumi-kenkyu@office.hiroshima-u.ac.jp
NO
広島大学病院 (広島県)
2019 | Year | 03 | Month | 28 | Day |
Published
60
Completed
2019 | Year | 03 | Month | 06 | Day |
2019 | Year | 03 | Month | 22 | Day |
2019 | Year | 05 | Month | 07 | Day |
2021 | Year | 08 | Month | 31 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 10 | Month | 31 | Day |
60 participants were already entered.
2019 | Year | 03 | Month | 27 | Day |
2022 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041189
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