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

Phramongkutklao College of Medicine and Hospital

Status: Enrolling

Conditions: Fatty Liver, Nonalcoholic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06491342

PMK GI 001

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner

Treatment:

Dietary Supplement: Placebo

probiotic

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Probiotic