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

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.

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Background: The change from prescription to over-the-counter (OTC) status of oral antihistamines may raise concerns about drug safety due to the possibility of misuse/abuse. In most European countries, oral antihistamines are available without prescription, whereas in Italy, only <10-tablet packs are available OTC.

Objectives: To evaluate the safety profile of fexofenadine after OTC switch in Italy in a real-world setting, and to compare its safety profile to that of other European countries where larger pack sizes are available.

Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies.

Unlabelled: BACKGROUND AND OBJECTIVE: Probiotics are live microorganisms that may provide benefits including the prevention of gastrointestinal disorders and other diseases. Enterogermina is a probiotic mix of spores from four strains of Bacillus clausii (O/C, T, N/R and SIN), available in several oral formulations. The objective of this analysis was to evaluate and compare the kinetic profiles of different formulations of Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule [EC2 three times daily (TID)], oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD) from two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27).