Clinical trial: Impact of Probiotical® on asthma control and inflammation

Abstract

Introduction: Probiotics are known to possess anti-inflammatory properties, to modulate the immune system and to have a really good tolerance and safety.

Objectives: The goal of this study was to investigate the effect of Probiotical® in uncontrolled asthma. The primary outcome was to evaluate if Probiotical® induced a better asthma control. The secondary outcomes were to observe whether it provoked a decrease of exhaled nitric oxide (FeNO) value and of blood and/or sputum eosinophil proportion.

Methods: We performed a double-blind, placebo-controlled, randomized trial (Clinicaltrial.org ID: NCT03341403) by recruiting 46 uncontrolled asthmatics. The patients were asked to take Probiotical® 3 times a day for 3 months. The ACQ scores, lung function tests, FeNo values, blood and sputum differential leucocyte counts, IgE levels, CRP and fibrinogen values were obtained before taking the probiotics as well as 3 months after.

Results: Our preliminary results showed that, in the probiotic group, the ACQ value decreased significantly when baseline and 3 months were compared (2.92 ± 0.67 vs 2.21 ± 1.01, p <0.05), which was not the case in the placebo group (2.30 ± 1.07 vs 2.07 ± 1.09, p=0.29). A decline at 3 months was also observed in the probiotic group for the sputum eosinophil percentage : ((0.5 (0.0-2.3) vs 0.1 (0.0-0.5), p <0.05)) compared to controls ((4.5 (1.45-9.3) vs 2.4 (1.2-9.4), p=1.00)).

Conclusions: This clinical trial showed evidence of a positive effect of Probiotical® in not optimally controlled asthma. Indeed, Probiotical® improved asthma control and reduced airway eosinophilic inflammation. This project was financially supported by the European Union (Interreg 5-a Euregio Meuse Rhine).