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

RationaleThe gut-lung axis describes the crosstalk between the gut and lung wherein microbiota in the gut modulate systemic anti-inflammatory and immune responses in the lungs. Objectives: We hypothesized that a blend of probiotic bacteria (Lactobacilli) combined with herbal extracts (resB(R)) could improve quality of life in COPD patients. MethodsWe conducted a randomized, double-blinded, placebo-controlled study (NCT05523180) evaluating the safety and impact of resB(R) on quality of life in volunteers with COPD. Participants took two capsules of resB(R) or placebo orally daily for 12 weeks. The primary endpoint was quality of life changes by Saint Georges Respiratory Questionnaire (SGRQ). In addition to safety, exploratory endpoints included changes in serum and sputum biomarkers as well as sputum and stool microbiome. Measurements and Main ResultsresB(R) was well tolerated by all participants, with no related adverse events reported. Participants who received resB(R) had improvement in their SGRQ symptom scores from baseline to final visit (P<0.05), while the change in SGRQ symptom scores in those receiving placebo was not significant. Serum and sputum concentrations of matrix metalloproteinase 9, serum c-reactive protein, and serum interleukin 6 decreased (P<0.05) between baseline and final visit in the resB(R) group, corresponding with an increase in stool Lactobacilli abundance. Relative abundance of Veillonella also increased in stool and sputum in the resB(R) group. ConclusionsParticipants with COPD who received resB(R) improved in respiratory symptoms over a 12-week course. Serum and sputum biomarkers suggest administration of the probiotic and herbal blend reduces inflammation and may thereby attenuate symptoms.