Double-Blind Randomized Placebo-Controlled Trial of a Lactobacillus Probiotic Blend in Chronic Obstructive Pulmonary Disease

Abstract

Introduction: Gut microbiota modulate systemic anti-inflammatory and immune responses in the lungs, suggesting a potential to support lung health through probiotic supplementation. We hypothesized that a probiotic blend (Lactobacilli) combined with herbal extracts (resB®) could improve quality of life in patients with chronic obstructive pulmonary disease (COPD). Methods: We conducted a randomized, double-blinded, placebo-controlled study (NCT05523180) evaluating the safety and impact of resB® on quality of life in volunteers with COPD. Participants took resB® or placebo (two capsules daily) for 12 weeks. The primary endpoint was change in quality of life by Saint George’s Respiratory Questionnaire (SGRQ). Secondary outcomes included safety, serum and sputum biomarkers, and microbiome analysis. resB® was well tolerated with no related adverse events. Results: Participants receiving resB® showed significant improvement in SGRQ symptom scores (P < 0.05), while placebo recipients did not. In the resB® group, serum and sputum levels of matrix metalloproteinase 9, C-reactive protein, and interleukin 6 decreased (P < 0.05), correlating with increased stool Lactobacilli. Additionally, Veillonella abundance increased in both stool and sputum. Conclusion: These findings suggest that resB® improves respiratory symptoms and reduces inflammation in patients with COPD, potentially by modulating gut and lung microbiota. Trial Registration: ClinicalTrials.gov identifier NCT05523180.