UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051940 |
|---|---|
| Receipt number | R000059259 |
| Scientific Title | Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver function -Placebo-controlled, double-blind, randomized, parallel-group comparative study- |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2024/06/18 15:51:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver function
Acronym
Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver function
Scientific Title
Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver function -Placebo-controlled, double-blind, randomized, parallel-group comparative study-
Scientific Title:Acronym
Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver function -Placebo-controlled, double-blind, randomized, parallel-group comparative study-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on liver function of ingestion of test food for 12 consecutive weeks, using placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Liver function markers
Key secondary outcomes
Inflammation markers
Subjective index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 12 consecutive weeks
Interventions/Control_2
Intake of placebo for 12 consecutive weeks
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years old
(2) Male with gamma-GTP level in the range from 61 to 100 IU/L or female with 31 to 65 IU/L, or subjects with ALT and AST level in the range from 31 to 50 IU/L
(3) Subjests who recievedd sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria
(1) Subjests with heart, liver, and kidney diseases (including complications of other deseases)
(2) Subjests with a history of cardiovascular disease
(3) Subjests with diabetes
(4) Subjests with diseases currently being treated
(5) Subjests who are allergic to food and drugs
(6) Subjests with anemia symptoms
(7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating gemale subjects
(8) Subjests who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible)
(9) Subjests who play intense sports and subjects who are on a diet
(10) Subjests with extremely irregular eating habits
(11) Subjests who may change their lifestyle habits (various daily habits such as diet, exercise, smoking, drinking, and sleeping) during the intake period
(12) Subjests who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(13) Subjests who drink more than 60g of avarage daily pure alcohol
(14) Subjests who smoke an average of 21 or more cigarettes a day
(15) Subjests who are participating in or will participate in other clinica trials at the start of this study
(16) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka,
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.jp
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
医療法人花音会みうらクリニック（大阪府）
Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 20 | Day |
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
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059259
