Exploratory clinical trial for the evaluation of the efficacy and safety of Streptococcus thermophilus LM1012 on improving liver functio

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0008108
• Lead Sponsor: actomason

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-15
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) 19 ~ 70 years of age
2) ALT level 35~105 IU/L
3) Subjects who agree to participated in the study and sign the informed consent form

Exclusion Criteria

1) AST or GGT > 3-fold of normal range
2) Subjects who usually drink alcohol as follows within 3 months
- Male > 210 g/weeks
- Female > 140 g/weeks
3) Patients with acute or chronic hepatitis or carriers of viral hepatitis (type B or C)
4) History of underlying cirrhosis and liver cancer
5) History of underlying biliary diseases such as jaundice or gallstones (But, asymptomatic gallstones etc. can be enrolled under the judgment of the researcher)
6) Patients who have clinically significant acute or chronic cardio-cerebrovascular systems, hepatic, musculoskeletal, neurologic, psychiatric, endocrine systems, immune, renal, malignant tumor and pulmonary disease etc.
7) Administration of antibiotic within 2 weeks before screening visit
8) Intake of probiotics or fermented milk products (yogurt, cheese, etc.) within 2 weeks before screening visit(more than 4 times/week)
9) Administration of drugs that affect liver function (antiviral drugs, antituberculosis drugs, antiseizure drugs, arthrifuge, antidepressant, lipid-lowering agents, anesthetic agents, hepatoprotective agents etc.), adrenal cortex hormones or sex hormone within 4 weeks before screening visit
10) Taking the liver function improving supplements (Milk thistle etc.), oriental medicine, OTC(Over The Counter) within 2 weeks before the screening visit
11) Allergic or hypersensitivity to drug and any of the ingredients in the test products (probiotics, crystalline cellulose etc.)
12) Subjects who have past history or currently in the treatment of significant clinical disease related to liver biliary system, kidney, nervous system(central or peripheral), respiratory system(asthma etc.), endocrine system(uncontrolled hyperlipidemia, thyroid disorder etc.), cardiovascular system(congestive heart failure, coronary artery disease, myocardial infarction etc.), blood neoplastic, urinary system, psychiatric, musculoskeletal system, immune system(rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency diseases)
13)History of substance abuse
14) History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
15) Those who have participated in other studies within 3 months before screening
16) Pregnant, planning to become pregnant, or breast-feeding
17) Female subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility)
18) Laboratory test by show the following results
? Serum creatinine > 2.0 mg/dL
19) A person who is determined by the test manager to be unsuitable for participation in the study due to other reasons, including the results of diagnostic tests.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALT(Alanine transaminase);GGT(Gamma-glutamyltransferase)

Secondary Outcome Measures

Name	Time	Method
AST (Aspartate Transaminase);ALP (Alkalin Phosphatase);Total bilirubin;Total cholesterol;Triglyceride;High density lipoprotein cholesterol;Low Density lipoprotein cholesterol;High sensitivity C-reactive protein(hs-CRP);Fatty liver index;Cytokines: TNF-a, IL-6;Multidimensional fatigue scale(MFS)