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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016849 |
Receipt No. | R000019416 |
Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria. |
Date of disclosure of the study information | 2015/03/25 |
Last modified on | 2015/11/16 |
Basic information | ||
Public title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
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Acronym | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
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Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
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Scientific Title:Acronym | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
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Region |
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Condition | |||
Condition | Healthy adult | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety of excessive consumption of beverage containing heat-killed lactic acid bacteria for 4 weeks in healthy adult |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Medical examination by blood biochemistry, hematology, urinalysis, physical examination at 2-week, 4-week consumption and 2 weeks after the end of consumption period. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Beverages containing heat-killed lactic acid bacteria, 4 weeks excessive consumption. | |
Interventions/Control_2 | Beverages not containing heat-killed lactic acid bacteria, 4 weeks excessive consumption. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) (Healthy) subjects aged 20 to 64 years old.
(2) Subjects giving written informed consent. |
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Key exclusion criteria | (1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.
(2) Subjects taking any kind of medicine which affect the result of the trial for habitual use. (3) Subjects daily consuming supplements or foods containing lactic acid bacteria. (4) Subjects presenting known food allergy or hay fever. (5) Subjects who are judged as unsuitable for the study by the investigator for the other reasons. |
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Target sample size | 44 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | C'est la vie Shimbashi Clinic | ||||||
Division name | Medical office | ||||||
Zip code | |||||||
Address | 2-39-3 Nishishimbashi, Minato-ku, Tokyo | ||||||
TEL | 03-5408-8671 | ||||||
h-sugimura@shinkokai.jp |
Public contact | |||||||
Name of contact person |
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Organization | KSO Corporation | ||||||
Division name | Sales department | ||||||
Zip code | |||||||
Address | 1-9-7 Shibaura, Minato-ku, Tokyo | ||||||
TEL | 03-3452-7733 | ||||||
Homepage URL | |||||||
yoshikawa@kso.co.jp |
Sponsor | |
Institute | KSO Corporation |
Institute | |
Department |
Funding Source | |
Organization | Kirin 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 | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019416 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |