A Prospective Real-World Study of Bacillus clausii Evaluating Use, Treatment Habits and Patient Satisfaction in Italian Community Pharmacies: The PEGASO Study

Abstract

Background Ailments such as diarrhoea and antibiotic-associated gut symptoms are generally self-managed using probiotics. Real-world data on reasons behind self-medication with over-the-counter (OTC) products and patient-reported outcomes can be investigated strategically by the pharmacists. Objective This study evaluates the use of Bacillus clausii (Enterogermina ® ) at the Italian community pharmacies among self-medicating patients, their treatment habits and perceived benefits. Design This is a multicentre, prospective, non-interventional study which included two visits [at screening (T0) and end of the study (T1) when symptoms had subsided, ≤ 30 days from T0]. Patients who were already inclined to buy B. clausii were enrolled and instructed to complete a questionnaire at T0 and T1. The primary objective was to evaluate the reasons for taking B. clausii . Secondary objectives assessed treatment duration, perceived effectiveness, quality of life (QoL), treatment satisfaction and safety outcomes. Results Overall, 268 patients were enrolled; 99.6% of them were evaluated at T0 and 97.4% at T1, and safety was evaluated in 97.8% who had ≥ 1 dose of B. clausii . At T0, mean age was 50.7 years and majority were females (62.2%). In the interview, main reason stated for using B. clausii at T0 was diarrhoea (56.93%), followed by other gastrointestinal symptoms. Treatment duration was shorter in those with diarrhoea or abdominal pain versus those with constipation or abdominal tension. More than 90% perceived their symptoms to have improved or improved very much. Overall QoL improved in all the aspects measured. Treatment satisfaction was reported by nearly 90% of patients as satisfied, very satisfied or extremely satisfied. No adverse events were reported. Conclusion This is the first pharmacy-based study in Italy that evaluated the real-world usage of an OTC probiotic containing B. clausii among self-medicating adults. Diarrhoea was the most common reason for use, with high-level of perceived effectiveness and patient satisfaction with B. clausii . Supplementary Information The online version contains supplementary material available at 10.1007/s40801-023-00402-1.