Three months of Lactobacillus rhamnosus lysate DV-NRRL B-68023 was well tolerated; among the three registered co-primary surrogate indices, only FLI showed a nominal between-group difference (HSI and TyG did not), with an exploratory reduction in waist circumference while ALT and AST changes were not significantly different from placebo.
Key Findings
Results
The Fatty Liver Index (FLI) showed a nominal time-by-treatment interaction favoring the postbiotic in the ITT analysis.
ITT analysis included 52 adults with MASLD randomized 1:1 (26 postbiotic, 26 placebo).
Time-by-treatment interaction for FLI: p = 0.049.
Between-group difference in change at month 3 was -7.20 points (95% CI: -12.95 to -1.46).
FLI was one of three registered co-primary endpoints; the result is described as nominal.
Results
The other two registered co-primary endpoints, the Hepatic Steatosis Index (HSI) and the triglyceride-glucose index (TyG), did not differ significantly between groups.
Co-primary endpoints registered were FLI, HSI, and TyG.
Only FLI showed a nominal between-group difference.
Intervention was Del-Immune V® Extra (100 mg twice daily) for 3 months versus placebo, followed by 3 months without treatment.
Results
Waist circumference showed a significant time-by-treatment interaction in exploratory ITT analyses, whereas visceral fat did not.
Waist circumference time-by-treatment interaction: p = 0.003.
Visceral fat interaction was not significant (p = 0.079).
These analyses were exploratory rather than registered co-primary endpoints.
Results
ALT and AST decreased significantly within the postbiotic group, but changes were not significantly different from placebo.
Time-by-treatment interaction for ALT: p = 0.340.
Time-by-treatment interaction for AST: p = 0.111.
The within-group decreases therefore did not translate into significant between-group differences.
Results
Lipid parameters and hs-CRP did not differ significantly between the postbiotic and placebo groups.
Lipid parameters and hs-CRP were secondary/additional outcomes.
No significant between-group differences were reported.
Results
The postbiotic was well tolerated, with only mild, self-limiting adverse events.
All adverse events were mild and self-limiting.
Randomized, double-blind, placebo-controlled trial (NCT06352697) with 52 adults.
Conclusions
The authors conclude that the findings require confirmation in larger studies using direct liver assessments and longer follow-up.
The study relied on non-invasive surrogate indices rather than direct liver assessment.
The study was short-term: 3 months of treatment plus 3 months of untreated follow-up.
Sample size was small (n = 52).
What This Means
This study tested whether a supplement made of dead (non-viable) Lactobacillus rhamnosus bacteria components, called a postbiotic, could help people with metabolic dysfunction-associated steatotic liver disease (fatty liver). Fifty-two adults were randomly assigned to take either the supplement (100 mg twice a day) or a placebo for three months, followed by three months without treatment. Neither participants nor researchers knew who received which.
The results were mixed and modest. Of three pre-registered main measures of liver fat (all calculated from routine measurements rather than direct imaging or biopsy), only the Fatty Liver Index improved more with the supplement than placebo, and that result was only borderline (p = 0.049). The other two measures did not differ. Waist circumference dropped more in the supplement group in an exploratory analysis. Liver enzymes (ALT and AST) fell within the supplement group, but not significantly more than with placebo. Cholesterol-related measures and an inflammation marker did not differ between groups. Side effects were mild and went away on their own.
This research suggests the postbiotic is safe over three months but provides only limited evidence of benefit for fatty liver. Because the trial was small, short, and used indirect measures of liver fat, the authors say larger and longer studies with direct liver assessments are needed to confirm whether it truly helps.
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Savytska M, Ilkiv Y, Baka O, Christian E, Yerokhovych V, Kyriienko D, et al.. (2026). Lactobacillus rhamnosus Lysate for Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial.. Medicina (Kaunas, Lithuania). https://doi.org/10.3390/medicina62101893