Study to Investigate the Effect of L. Lactis CKDB001 Administration on Liver Aminotransferases in Subjects With NAFLD

Chuncheon Sacred Heart Hospital

Status: Completed

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics (L. lactis CKDB001)

Study type: Interventional

Funder types: Other

Identifiers

NCT07378280

CKDB001-01

Details and patient eligibility

About

A study for evaluating the safety and efficacy of L. lactis CKDB001 on liver aminotransferases in subjects with nonalcoholic fatty liver disease

Enrollment: 95 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women aged 19 to 75 years at the time of written consent
• Voluntarily provided written consent after receiving sufficient explanation about the study
• ALT or AST levels exceed the upper limit of normal, but are five times or less than the upper limit

Exclusion criteria

• Pregnant or breastfeeding women
• Women of childbearing potential and men who are unable or unwilling to use appropriate contraception during the study period
• Individuals with a history of alcohol abuse or chronic alcohol consumption:

Daily alcohol consumption averaging over 30g/day (210g/week) for men or over 20g/day (140g/week) for women

• Individuals with viral or other liver diseases that could affect study results:
• Individuals with a history of or current drug abuse
• Individuals with a history of psychiatric disorders or current psychiatric conditions that may interfere with the study
• Individuals with a history of major gastrointestinal surgery (excluding appendectomy, but including gastric resection, gastrointestinal bypass, anastomosis, bariatric metabolic surgeries)
• Individuals with severe comorbidities that make them unsuitable for study participation (e.g., heart disease, kidney disease, malignancy, immunosuppression, etc.):
• Regular consumption of probiotics, prebiotics, synbiotics, or fermented milk within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
• Regular consumption of medications, health supplements, or herbal remedies that may affect liver function or anti-inflammatory responses within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
• Use of medications that may cause hepatic steatosis (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, corticosteroids)
• Use of medications for treating non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH) within 3 months prior to screening (e.g., thiazolidinediones, vitamin E)
• Use of medications that may affect study results (e.g., antipyretic analgesics, NSAIDs, anti-tuberculosis drugs, antibiotics, anticonvulsants, choleretics, liver disease medications)
• Use of oral steroids, hormones, or drugs that may affect absorption, metabolism, or excretion of food within 4 weeks prior to screening (participation allowed if taking systemic steroids or thyroid hormones in stable doses for ≥3 months before screening)
• Use of hypoglycemic agents or lipid-lowering drugs (except insulin or thiazolidinediones) with stable doses for at least 3 months prior to screening
• Dietary or exercise therapies that may affect study within 3 months prior to screening
• Smokers consuming more than 20 cigarettes per day
• Allergies or digestive issues related to study food ingredients
• Weight loss exceeding 10% of previous body weight within 6 months prior to screening
• Participation in another clinical trial within 30 days prior to screening or not completing the required five-half-life period of investigational drug/food from a previous trial
• Any other individuals deemed unsuitable for the study by the investigator

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with placebo for 12 weeks. After treatment, primary and secondary outcomes were analyzed.

Treatment:

Dietary Supplement: Placebo

L. lactis CKDB001

Experimental group

Description:

The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with L. lactis CKDB001 (5.0E+09 CFU/day) for 12 weeks. After treatment, primary and secondary outcomes were analyzed.

Treatment:

Dietary Supplement: Probiotics (L. lactis CKDB001)