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.


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.

Publication types

  • Observational Study

MeSH terms

  • Complementary Therapies*
  • Humans
  • Irritable Bowel Syndrome* / diagnosis
  • Irritable Bowel Syndrome* / drug therapy
  • Probiotics* / therapeutic use
  • Prospective Studies
  • Treatment Outcome