Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

Not Applicable

Recruiting

• Conditions: Fatty Liver, Nonalcoholic
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT06491342
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Detailed Description

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile

Study Timeline

• Study Start: 2023-07-25
• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-06-30
• Study First Posted: 2024-07-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12-28
• Study Completion: 2025-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Male and female adults ≥20,<80 years of age who suspected or confirmed diagnosis of NASH/NAFLD suggested by the historical data, they must meet one of the following criteria:

Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD

Exclusion Criteria

1. Supplement with probiotic/prebiotic within 2 weeks

2. Previous antibiotic/antifungus within 1 month

3. History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females

4. Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d

5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis

6. Hepatic decompensation or impairment defined as presence of any of the following:

   • History of esophageal varices, ascites or hepatic encephalopathy.
   • Serum albumin <3.5 g dl-1, except as explained by nonhepatic causes.
   • INR > 1.4

7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone

8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease

9. Active malignancy on treatment

10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction <30%

11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections

12. Respiratory compromised

13. Severe renal impairment (eGFR <30 ml/min/1.73 m2)

14. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner
probiotic	Probiotic	Lactobacillus Zeae and Lactobacillus reuteri probiotic mixed with Maltodextrin in ratio 15:85 in bovine gelatin capsule (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner (1,000 mg =1x109 CFU/g)

Primary Outcome Measures

Name	Time	Method
Liver stiffness by fibroscan	12 weeks	Fibroscan- transient elastography in kilopascals (kPa)
Liver steatosis by fibroscan	12 weeks	Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)
Liver steatosis by MRI	12 weeks	Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent

Secondary Outcome Measures

Name	Time	Method
Metabolic profile: serum lipid profiles	12 weeks	Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL
Metabolic profile	12 weeks	HbA1C in percent
Inflammatory marker	12 weeks	Interleukin 6 (IL-6) in pg/mL
Anthropomorphic evaluation	12 weeks	Body muscle in kilogram
Liver inflammation	12 weeks	Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L)
Metabolic profile: HOMA IR	12 weeks	Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L
Anthropomorphic evaluation: BMI	12 weeks	Weight and height will be combined to report BMI in kg/m\^2
Anthropomorphic evaluation: composition analysis	12 weeks	Body fat in percentage

Trial Locations

Locations (1)

Division of gastroenterology and hepatology; 🇹🇭 Ratchathewi, Bangkok, Thailand