Non-Alcoholic Fatty Liver Disease
Conditions
Interventions
Bifidobacterium adolescentis CCFM1061 group:Bifidobacterium adolescentis CCFM1061
Placebo group:Placebo
Sponsors
Yixing People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Meet the diagnostic criteria for non-alcoholic fatty liver disease (NAFLD); (2)Age between 18 and 65 years (inclusive), with no restriction on gender; (3)Overweight or obese (BMI between 25 and 35) with waist circumference >90 cm for males and >85 cm for females; (4)Good compliance and ability to adhere to the clinical trial requirements; (5)The subject or their legal guardian has signed the informed consent form; (6)The participant has completed a written informed consent form, the International Physical Activity Questionnaire (IPAQ), and the dietary structure questionnaire, and has committed to cooperating with the study throughout the trial.
Exclusion criteria
Exclusion criteria: (1) Alcohol intake equivalent to >40 g/week; (2) Regular use of non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, corticosteroids, anti-tumor drugs, anti-tuberculosis drugs, or certain traditional Chinese herbs and mineral drugs (e.g., chaulmoogra oil/arsenic trioxide) in the past 6 months; (3) Substance abuse involving narcotics, psychotropic drugs, or cigarettes within the past 6 months; (4) Use of medications in the past 6 months that cause hypochlorhydria, including amiodarone, valproic acid, prednisone, tamoxifen, perhexiline, methotrexate, lipid-inducing drugs, hormonal agents, statins, antihypertensives, and ursodeoxycholic acid or antisecretory agents; (5) Consumption of supplements such as probiotics, multivitamins/minerals, antioxidants, or omega-3 fatty acids at least twice a week during the study or in the past 3 months; (6) Presence of conditions affecting liver pathology, including cholestasis, liver transplant, acute systemic diseases, cystic fibrosis, muscular dystrophy, neurological disorders, gastrointestinal structural abnormalities, diabetes, heart failure, thyroid diseases, inflammatory bowel disease, kidney diseases, respiratory failure, hereditary hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, autoimmune diseases, celiac disease, or any form of malignancy; (7) Presence of a cardiac pacemaker, implanted insulin pump, cochlear implant, magnetic metallic foreign body in the eye orbit, or ECG monitoring devices incompatible with MRI; (8) Rapid weight loss, total parenteral nutrition, or protein malnutrition within the past 6 months; (9) Pregnant or lactating women; (10) Allergy or intolerance to any components of the probiotic product used in the trial; (11) Poor compliance or low likelihood of adhering to follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight;Fecal flora;Hepatic function;Blood fat;Blood sugar;Fecal routine;HbA1c; | — |
Countries
China
Contacts
Public ContactLuo Yifeng
Yixing People's Hospital
Outcome results
None listed