Unique ID issued by UMIN | UMIN000037329 |
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Receipt number | R000042491 |
Scientific Title | Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose. |
Date of disclosure of the study information | 2020/11/02 |
Last modified on | 2021/06/25 09:39:45 |
Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.
Japan |
N/A (healthy adults)
Not applicable | Adult |
Others
NO
This study aims to examine effect of a food containing lactic acid bacteria to eyes and nose and its safety.
Safety,Efficacy
[1]The discomfort of eyes and nose in the daily life (JRQLQ NO.1, level of allergic rhinitis, level of local findings, eye- and nose- symptoms based on subject's diary, and effect measurement) (Screening, Week 0, Week 4, Week 8, Week 12, Week 16).
*Secondary outcomes
[1]Japanese edition of Profile of Mood States (2nd edition) (Week 0, Week 8, Week 16).
[2]Nasal eosinophil count (Screening, Week 4, Week 8, Week 12, Week 16).
[3](1)Eosinophil count, (2)nonspecific IgE, (3)specific IgE, (4)thymus and activation-regulated chemokine.
[4]Saliva sIgA (Week 0, Week 8, Week 16).
(1)Week 0, Week 4, Week 8, Week 12, Week 16.
(2)Screening, Week 4, Week 8, Week 12.
(3)Screening, Week 8, Week 16.
(4)Week 0, Week 8, Week 16.
*Safety
[1]Hematologic test (Screening, Week 0, Week 8, Week 16).
[2]Blood biochemical test (Screening, Week 0, Week 8, Week 16).
[3]Urine analysis (Screening, Week 0, Week 8, Week 16).
[4]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12, Week 16).
[5]Weight, body fat percentage, BMI (Week 0).
[6]Doctor's questions (Week 0, Week 4, Week 8, Week 12, Week 16).
*Other indexes
[1]Questionnaire for allergic rhinitis (Week 0).
[2]Subject's diary(From 3 days prior to the first day of ingestion of a test material to the last day of the test).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Oral intake of the test product (1 piece in a day; 16 weeks).
Oral intake of the placebo product (1 piece in a day; 16 weeks).
20 | years-old | <= |
65 | years-old | > |
Male and Female
[1]Japanese males and females aged 20-65 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with allergic rhinitis-symptoms.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
[1]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC).
[2]Individuals using medical products.
[3]Individuals who are a patient of or have a history of bronchial disease.
[4]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollinosis).
[6]Individuals who are sensitive to a test food.
[7]Individuals who are sensitive to foods, and medical products.
[8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[9]Individuals who are a patient or have a history of or endocrine disease.
[10]Individuals whose BMI is over 30 kg/cm2
[11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12]Individuals who have a habit of intaking
fermented milk food (over 3 times in a week).
[13]Individuals who cannot restrict to eat bactic acid bacteria rich food after informed consent.
[14]Individuals who had a habit to ingest bifidobacteria enriched food or food for specified health uses or foods with Function Claims which adopt to ease allergy symptoms in the past 1 month or will ingest those foods during the test period.
[15]Individuals who excessively take alcohol expressed in an amount of alcohol over 60g/day.
[16]Individuals whose life style will change during the test period.
[17]Individuals who are or are possibly pregnant, or are lactating.
[18]Individuals who participated in other clinical studies in the past 3 months.
[19]Individuals who are or whose family is an employee of a health food company.
[20]Individuals judged inappropriate for the study by the principal.
200
1st name | Takahiro |
Middle name | |
Last name | Ono |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinc
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.c.jp
TES Holdings Co., Ltd.
Megmilk Snow Brand Co., Ltd.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
+81-3-6240-1162
jimukyoku@tes-h.co.jp
NO
2020 | Year | 11 | Month | 02 | Day |
Unpublished
Completed
2019 | Year | 06 | Month | 24 | Day |
2019 | Year | 06 | Month | 26 | Day |
2019 | Year | 08 | Month | 17 | Day |
2019 | Year | 12 | Month | 10 | Day |
2019 | Year | 07 | Month | 10 | Day |
2021 | Year | 06 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042491
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