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Effect of probiotics on liver steatosis in non-alcoholic fatty liver disease patients : A randomized, double-blind, placebo-controlled trial

Effect of probiotics on liver steatosis in non-alcoholic fatty liver disease patients : A randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250317003
Enrollment
32
Registered
2025-03-17
Start date
2023-07-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Subjects with nonalcoholic fatty liver disease (NAFLD) NAFLD

Interventions

Biofit 1 tab oral twice a day for 12 weeks,Placebo 1 tab oral twice a day for 12 weeks
Experimental Drug,Placebo Comparator Drug
Probiotic arm,Placebo

Sponsors

Bhumibol Adulyadej Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with nonalcoholic fatty liver disease diagnosed by Fibroscan or liver biopsy

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of diagnosed chronic hepatitis B or chronic hepatitis C 2. Subjects diagnosed with autoimmune hepatitis. 3. Subjects diagnosed with liver cancer 4. Subjects diagnosed with hereditary liver disease. 5. Subjects who consume more than 30 grams of alcohol per day for men or more than 20 grams per day for women over 10 years, 6. Subjects taking herbal medicine or narcotic drugs suspected of causing hepatitis, 7. Subjects who have taken antibiotics, probiotics, or medications known to affect the liver within 6 months before the start of the study and during the study, 8. Subjects diagnosed with bile duct disease. 9. Pregnant women. breastfeeding women, and subjects with soybean allergies.

Design outcomes

Primary

MeasureTime frame
change of liver steatosis and fibrosis 12 weeks Controlled Attenuation Parameter score and liver stiffness measure

Secondary

MeasureTime frame
Alanine aminotransferase 12 weeks International unit

Countries

Thailand

Contacts

Public ContactChanunta Hongthanakorn

Bhumibol Adueyadej Hospital

rabbithap@yahoo.com0824591966

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026