Lactobacillus rhamnosus Lysate for MASLD: A Randomized Controlled Trial
Twelve weeks of L. rhamnosus DV-NRRL B-68023 lysate reduced biochemical steatosis indices, transaminases, and inflammatory markers versus placebo in adults with MASLD, but the trial is too small for definitive conclusions.
| Population | 52 adults (18–70 years) with MASLD confirmed by abdominal ultrasound, FLI >60, BMI 25–39.9 kg/m², AST and ALT ≤3× ULN, recruited at a clinical endocrinology centre in Kyiv, Ukraine |
|---|---|
| Intervention | Lyophilized enzymatic lysate of L. rhamnosus DV-NRRL B-68023 (Del-Immune V® Extra) 100 mg twice daily, oral, for 12 weeks |
| Comparator | Identical microcrystalline cellulose capsules (placebo) |
| Outcome | Fatty Liver Index (FLI); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Systemic inflammation markers (CRP, IL-6, TNF-α); Lipid profile (triglycerides, LDL); Anthropometric measures (BMI, waist circumference); Safety and adverse events |
Summary of findings
| Outcome | Effect | 95% CI | Certainty | Clinical relevance | Notes |
|---|---|---|---|---|---|
| Fatty Liver Index (FLI) | MD not fully reported with 95% CI in available text; statistically significant reduction in lysate vs placebo group at 12w | — | Low | — | 1 studies |
| Alanine aminotransferase (ALT) | MD not fully reported with 95% CI in available text; statistically significant reduction in lysate vs placebo group at 12w | — | Low | — | 1 studies |
| Aspartate aminotransferase (AST) | MD not fully reported with 95% CI in available text; statistically significant reduction in lysate vs placebo group at 12w | — | Low | — | 1 studies |
| Systemic inflammation markers (CRP, IL-6, TNF-α) | MD not fully reported with 95% CI in available text; statistically significant reduction in lysate vs placebo group at 12w | — | Low | — | 1 studies |
| Lipid profile (triglycerides, LDL) | MD not fully reported with 95% CI in available text; direction of effect favours lysate in available report | — | Low | — | 1 studies |
| Anthropometric measures (BMI, waist circumference) | MD not fully reported with 95% CI; modest or non-significant between-group differences suggested in available text | — | Low | — | 1 studies |
| Safety and adverse events | No significant between-group difference in adverse event rates; events reported as mild in both arms | — | Low | — | 1 studies |
Context
MASLD affects hundreds of millions globally and lacks widely accessible approved pharmacological treatments. The gut-liver axis is a rational therapeutic target. Postbiotics — non-viable microbial components — offer a more predictable safety profile than traditional probiotics, but clinical evidence in MASLD is sparse.
What the study showed
The lysate group showed statistically significant reductions in steatosis indices, transaminases, and inflammatory markers versus placebo at 12 weeks. The available text does not report complete 95% CIs or absolute effect sizes for all outcomes, limiting precise quantification. No histological endpoints were assessed (biopsy not performed). Adverse events were mild and similarly distributed between groups.
How it was done
Single-centre, double-blind, parallel-group, placebo-controlled RCT in Kyiv, Ukraine (n=52, 1:1 allocation). Twelve-week active intervention followed by 3-month post-treatment follow-up. Electronic stratified randomization by age, sex, and baseline severity; sequentially numbered opaque sealed envelopes. ITT analysis. Fourteen-day stabilization run-in with nutritional counselling before randomization.
Effect magnitude
The available text does not provide complete 95% CIs or standardized effect sizes for all primary outcomes; reported effects are statistically significant both within and between groups, but the absolute clinical magnitude cannot be fully quantified from the available excerpt.
Risk of bias
Sample size of 52 provides marginal statistical power and raises risks of type I and II errors; single-centre design limits generalizability. Absence of liver biopsy precludes histological confirmation. Diet and physical activity adherence assessed by self-report only, without objective quantification — an uncontrolled potential confounder. Risk-of-bias tool not explicitly declared by authors (RoB 2 would be applicable). Product supplied by the manufacturer represents a potential conflict of interest.
What this study does NOT prove
This study does not prove fibrosis reduction, prevention of MASH progression, or reduction of clinically relevant hepatic events. Results are not generalizable to patients with cirrhosis, BMI >40, normal-weight MASLD, or populations outside Eastern Europe.
In clinical practice
The lysate does not replace lifestyle intervention or approved treatments. In stable MASLD patients with BMI 25–39.9 and no other microbiome modulators, the short-term safety profile appears acceptable. Clinical adoption should await replication in larger studies with histological endpoints.
Limitations
Sample size of 52 provides marginal statistical power and raises risks of type I and II errors; single-centre design limits generalizability. Absence of liver biopsy precludes histological confirmation. Diet and physical activity adherence assessed by self-report only, without objective quantification — an uncontrolled potential confounder. Risk-of-bias tool not explicitly declared by authors (RoB 2 would be applicable). Product supplied by the manufacturer represents a potential conflict of interest.
What is still missing
Multicentre trials with >200 participants, histological confirmation (biopsy or validated elastography), minimum 52-week follow-up, and stratification by fibrosis stage are needed to establish clinically relevant efficacy.
Technical appendix
Version history
- 1.0 · 2026-10-28 — Auto-generated under Evidence Standard v1.0