Probiotics and intestinal permeability in adults with metabolic dysfunction‐associated steatohepatitis: A secondary analysis of a randomized clinical trial

Abstract Background Metabolic dysfunction‐associated steatohepatitis (MASH) is associated with altered intestinal permeability, allowing microbial products to translocate to the liver via the enterohepatic circulation and contributes to disease progression. The aim of our study was to evaluate the association between probiotic supplementation and serum claudin‐3 levels in patients with MASH. Methods We conducted a secondary analysis of a randomized, double‐blind, placebo‐controlled trial including adult outpatients with biopsy‐confirmed MASH (Activity Score >4). Participants received either a probiotic mixture ( Lactobacillus acidophilus, L. rhamnosus, L. paracasei, Bifidobacterium animalis subsp. lactis; 1 × 10 9 CFU or placebo (2 sachets/day) for 24 weeks. Serum claudin‐3 levels and dietary intake were assessed before and after the intervention. Changes were analyzed using Generalized Estimating Equations. Results Forty‐four patients completed the trial. Baseline claudin‐3 concentrations were similar between groups. After 24 weeks, serum claudin‐3 levels significantly decreased in both the probiotic (14.7 to 6.1 ng/mL) and placebo groups (16.7 to 6.0 ng/mL), with no significant between‐group difference. Both groups reported reduced intake of calories, carbohydrates, proteins, and fats, but no differences in weight or waist circumference. Conclusion In conclusion, serum claudin‐3 levels decreased significantly over the 24‐week study period in patients with MASH. However, probiotic supplementation did not result in additional reductions in intestinal permeability compared to placebo.