Minerva Medica 2021 Jun 11

DOI: 10.23736/S0026-4806.21.07015-4

Copyright © 2021 EDIZIONI MINERVA MEDICA

lingua: Inglese

Evaluation of tolerability and major factors affecting the adherence to probiotic therapy in patients with irritable bowel syndrome: a prospective, observational, real-life study

Lucrezia LATERZA, Marco NAPOLI, Valentina PETITO, Franco SCALDAFERRI, Eleonora GAETANI, Antonio GASBARRINI ✉

CEMAD Digestive Disease Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy

BACKGROUND: Probiotics have been evaluated in multiple clinical trials on irritable bowel syndrome (IBS). However, in real-life long-term compliance could be low. Our study is single-center, observational and prospective, aiming both to evaluate the adherence to prescription of probiotic therapy in real-life and to identify factors able to influence adherence to therapy.
METHODS: Fifty patients diagnosed with IBS according to Rome IV and receiving a clinical prescription of a multistrain probiotic preparation (VSL#3® manufactured by Nutrilinea Srl and marketed in Italy by Ferring S.p.A.) have been enrolled and 49 completed the follow-up. Two months after baseline a second visit was made to assess adherence and eventual reasons for discontinuation.
RESULTS: Sixty percent of patients took all the prescribed probiotic therapy in real-life setting, with perceived benefits in more than 60% of cases. Among the 20 patients with reduced adherence, 5 took less than 50%, 12 took 50% and 2 took more than 50% but less than 80% of the prescribed doses. Principal reasons of not complete adherence among the 20 patients were: price of the product (8/20), mild adverse events (AEs) (6/20) and poor appreciation of flavour (3/20).
CONCLUSIONS: This study suggested that the adherence to probiotic therapy is affected by different factors in patients with IBS in a real-life setting. The main reason for lack of adherence was the price of the product. Other reasons are mild AEs (mainly bloating) and low palatability.

KEY WORDS: Probiotics; Irritable Bowel Syndrome; Compliance; Safety