UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027440 |
|---|---|
| Receipt number | R000031440 |
| Scientific Title | Effect of lactic acid bacteria beverage on liver function |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2019/04/18 09:47:03 |
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Basic information
Public title
Effect of lactic acid bacteria beverage on liver function
Acronym
Effect of lactic acid bacteria beverage on liver function
Scientific Title
Effect of lactic acid bacteria beverage on liver function
Scientific Title:Acronym
Effect of lactic acid bacteria beverage on liver function
Region
| Japan |
Condition
Condition
Mild liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of lactic acid bacteria beverage containing live or dead Lactobacillus plantarum SN13T on liver function in subjects with mild liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
16-week changes in ALT, AST, and r-GTP
Key secondary outcomes
16-week changes in TC, HDL-C, TG, FBS, insulin, HOMA-IR, leptin, adiponectin, TNF-a, intestinal flora, and defecation frequency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects drink 120 mL/day of lactic acid bacteria beverage containing live Lactobacillus plantarum SN13T for 16 weeks.
Interventions/Control_2
Subjects drink 120 mL/day of lactic acid bacteria beverage containing dead Lactobacillus plantarum SN13T for 16 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
40<AST<100 U/L, 40<ALT<100 U/L, or 70<r-GTP<210 U/L for male; 30<r-GTP<90 U/L for female
Key exclusion criteria
1) Diagnosis of virus hepatitis, autoimmune hepatitis, or cirrhosis of liver
2) Taking drugs for chronic disease or continuously taking anti-flatulent, antibiotics, or purgative drug that possibly affects the intestinal flora
3) Allergy to milk
4) Participation in any clinical trial within 90 days of the commencement of the trial
5) In pregnancy or nursing a child
6) Judged as ineligible by clinical investigators
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
Homepage URL
fumiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 05 | Month | 23 | 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
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031440
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
