Evaluation of Health-Related Quality of Life in Patients Treated with Synbiotics: a Prospective Observational Study

Abdominal bloating and gastrointestinal discomfort are common complaints that significantly impair patients' health-related quality of life (HRQoL). Probiotic and synbiotic formulations have been proposed as supportive therapies for improving gastrointestinal symptoms and patient-reported outcomes, yet real-world data on their impact on HRQoL remain limited. Our objective was to evaluate changes in physical and mental components of HRQoL in adult patients treated with a synbiotic formulation containing Saccharomyces boulardii SB01, Lactobacillus bulgaricus LB42, Lactobacillus rhamnosus LRa05 and fructooligosaccharides (FOS) in routine clinical practice.

This prospective monocentric observational study included 50 adult patients treated with a synbiotic formulation containing Saccharomyces boulardii SB01, Lactobacillus bulgaricus LB42, Lactobacillus rhamnosus LRa05 and FOS for 15 days. Health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12) at baseline and at 30-day follow-up. Changes in SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were analyzed using Wilcoxon signed-rank tests. Clinically meaningful improvement was defined using the minimal clinically important difference (MCID). Effect sizes were calculated and correlations between changes in PCS and MCS were assessed using Spearman's rho.

The PCS scores improved significantly from baseline to follow-up (mean change +4.42, p-value= 0.003). Clinically meaningful improvement in physical HRQoL was observed in 46% of participants. In contrast, MCS scores declined significantly over the same period (mean change -9.17, p-value < 0.001) and no participants achieved MCID for mental HRQoL. Changes in physical and mental HRQoL were not significantly correlated (p-value = 0.112).

In routine clinical practice, treatment with the studied synbiotic formulation was associated with a statistically significant and clinically meaningful improvement in physical HRQoL, while mental HRQoL showed a significant decline over the short-term follow-up. These findings highlight divergent trajectories of physical and mental health outcomes and underscore the importance of multidimensional HRQoL assessment in patients with gastrointestinal disorders.