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

Minerva Med. 2023 Apr;114(2):203-209.doi: 10.23736/S0026-4806.21.07015-4. Epub 2021 Jun 11.


Lucrezia Laterza 1Marco Napoli 1Valentina Petito 1Franco Scaldaferri 1Eleonora Gaetani 1Antonio Gasbarrini 2


Author information

1CEMAD Digestive Disease Center, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy.

2CEMAD Digestive Disease Center, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy - antonio.gasbarrini@unicatt.it.


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., Milan, Italy) 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.

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