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

A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Investigate the Effect of L.lactis CKDB001 Administration on Liver Aminotransferases in Subjects with Nonalcoholic Fatty Liver Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007388

Enrollment

120

Registered

2022-06-14

Start date

2021-10-08

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : test product: capsule that contains the L. lactis CKDB001 comparator product: matching placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Change of aminotransferase(AST, ALT) levels	—

Secondary

Measure	Time frame
Chang of liver function, lipid, glucose, HbA1c, cytokine, fatigue severity scale	—

Countries

Korea, Republic of

Contacts

Public ContactKitae Suk

Hallym University Medical Center- Chuncheon

ktsuk@hallym.ac.kt+82-2-010-5365

Outcome results