The effects of next generation probiotics on metabolic dysfunction-associated steatotic liver disease: a parallel, double-blind, randomized, placebo-controlled trial.

LL001 (Lactobacillus delbrueckii subsp. Lactis) treatment significantly improved alanine transaminase (ALT) levels in patients with MASLD.

• ALT decreased from 87.3 ± 8.2 to 71.1 ± 6.0 U/L (P = 0.01) over 8 weeks.
• The LL001 group received 3 capsules (9 × 10^9 CFU)/day alongside silymarin.
• The trial was a double-blind, parallel, randomized, placebo-controlled design with 110 patients total.

LL001 treatment significantly improved aspartate transaminase (AST) levels in patients with MASLD.

• AST decreased from 64.9 ± 4.9 to 50.0 ± 3.5 U/L (P < 0.01) over 8 weeks.
• The LL001 group was part of a four-arm trial comparing three different probiotic strains and placebo.
• All probiotic groups also received silymarin as a co-treatment.

LH001 (Lactobacillus helveticus) treatment was associated with a significant reduction in body weight.

• Body weight decreased from 78.4 ± 3.0 to 77.2 ± 2.8 kg (P = 0.01) over 8 weeks.
• The LH001 group received 9 × 10^9 CFU/day for 8 weeks alongside silymarin.
• The total probiotic group comprised 85 participants across three probiotic arms, with 25 in the placebo group.

PPKID7 (Pediococcus pentosaceus KID7) treatment significantly reduced total cholesterol levels.

• Cholesterol levels decreased from 186.1 ± 7.0 to 178.0 ± 7.9 mmol/L (P = 0.03) over 8 weeks.
• The PPKID7 group received 9 × 10^9 CFU/day alongside silymarin.
• Each of the three probiotic strains demonstrated distinct primary effects on different metabolic parameters.

LL001 probiotic treatment was associated with shifts in gut microbiome composition, specifically decreasing Proteobacteria and increasing Ruminococcaceae and Lachnospiraceae.

• 16S rRNA gene sequencing of stool samples was performed at baseline and after 8 weeks of treatment.
• Decreased abundance of Proteobacteria was observed in the LL001 group post-treatment.
• Increased abundance of Ruminococcaceae and Lachnospiraceae was observed in the LL001 group.
• Stool samples were collected at the start and end point of the study for microbiome analysis.

Probiotic treatment showed a tendency to alter gut microbiota at the genus level, decreasing Haemophilus and Ruminococcus_g2 while increasing Bifidobacterium.

• Analysis was performed at the level of the top 20 genera in pre- and post-comparison of probiotic treatment.
• A tendency (not explicitly stated as statistically significant) was observed to decrease genera Haemophilus and Ruminococcus_g2.
• A tendency was also observed to increase the genus Bifidobacterium following probiotic supplementation.
• 16S rRNA gene sequencing was the methodology used for microbiome characterization.

The trial enrolled 110 patients diagnosed with MASLD who were randomized to probiotic or placebo groups in a double-blind, parallel design.

• Participants were randomly assigned to four groups: three probiotic groups (n = 85 total) or placebo (n = 25).
• Each probiotic group received 3 capsules (9 × 10^9 CFU)/day of one of three strains: LL001, LH001, or PPKID7, alongside silymarin.
• The intervention duration was 8 weeks.
• The primary endpoint was improvement in liver function.
• Clinical characteristics, serum samples, and stool samples were collected at baseline and endpoint.