A human study to Investigate the Effect of L.lactis CKDB001 Administration on Liver Aminotransferases in Subjects with Nonalcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0007388
• Lead Sponsor: Chong Kun Dang Bio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-07
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Voluntarily decides to participate in this clinical study and signs the informed consent
2) Men and women aged 19 to 75 years inclusive at the time of signing the informed consent
3) upper limit of normal (ULN) < ALT or AST = 5 x upper limit of normal (ULN)

Exclusion Criteria

1) A history of significant alcohol abuse or chronic alcoholic consumption
2) Viral liver disease and other liver diseases that may affect the results
3) Regularly intake of probiotics, prebiotics, synbiotics, fermented milk products within 4 weeks before screening visit
4) Use of drugs historically associated with hepatic steatosis
5) Use of drugs for the treatment of NAFLD or NASH within 3 months prior to screening, etc.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Change of aminotransferase(AST, ALT) levels

Secondary Outcome Measures

Name	Time	Method
Chang of liver function, lipid, glucose, HbA1c, cytokine, fatigue severity scale