BACKGROUND: Emerging evidence suggests that oral probiotics may enhance the immune response in respiratory diseases, offering potential benefits in managing Chronic Obstructive Pulmonary Disease (COPD). OBJECTIVES: This trial aims to evaluate whether the addition of the oral probiotic Familact to standard therapies significantly enhances dyspnea management in COPD patients compared to standard treatment alone. METHODS: In this single-blind randomized clinical trial 60 COPD patients randomly allocated into the control and intervention groups (n = 30). Over three months, the control group received standard treatment, while the intervention group received standard treatment plus oral Familact. Spirometry was conducted twice, and dyspnea was assessed four times using the Borg Scale Ratings (BORG) and Modified Medical Research Council Dyspnea Scale Scores in COPD patients (MMRC) scales and were evaluated using repeated measurement analysis. RESULTS: No significant change was observed in FEV1 post-intervention, but MMRC and BORG scores showed a statistically significant improvement in the intervention group compared to the control group (P <
0.01). Repeated measures tests based on estimated marginal means revealed significant MMRC differences within groups over time, with inter-group differences notable only between the first and second measurements. BORG showed significant within- and between-group differences at all time points, confirmed by post hoc tests. CONCLUSION: This study demonstrates that Familact, as an oral probiotic can significantly alleviate dyspnea in COPD patients, as reflected in notable improvements in BORG and MMRC scores. These findings underscore the potential of probiotics as an adjunctive therapy for COPD, particularly in improving patient-reported outcomes related to respiratory difficulty.