UMIN-CTR Clinical Trial

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
Last 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
Email	fumiko@hiroshima-u.ac.jp

Public contact
1st 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
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031440