OBJECTIVES: Aim of this Real World (RW) research was to investigate the effectiveness and safety of the vegetal molecular complex ActiMucin in Irritable Bowel Syndrome (IBS) patients with diarrhea predominant (IBS-D), constipation predominant (IBS-C) and mixed (IBS-M) clinical subtypes.

METHODS: Between March and October 2021, a cohort of 77 hospital gastroenterologists uniformly distributed throughout Italy and with at least one year’s experience with the use of this medical device (MD) were asked to complete an electronic questionnaire designed to collect information also on symptoms, co-treatments, and quality of life in IBS patients.

RESULTS: For the majority of physicians, overall effectiveness was evaluated as good (66.2%) or excellent (24.7%). In particular, more than half of gastroenterologists (57.1%) reported that patients experienced an improvement in their symptoms within the first month of use. This also led to an important improvement in the quality of life (good 66.2%, excellent 18.2%), evaluated in terms of mood, social life, work and freedom of nutrition. Furthermore, 72.7% of gastroenterologists considered the treatment effective for all types of IBS. Moreover, it allowed to reduce the use of other symptomatic therapies in 66.2% of the cases. As for safety evaluation, tolerability was considered excellent for the 70.1% of the respondents and no adverse events were reported.

CONCLUSIONS: RW data obtained through surveys allow to properly deal with post-market monitoring and confirmation of relevant general safety and performance requirements, throughout the product lifespan, as per EU Regulation 2017/745 on MDs. The MD benefit-to-risk assessment on larger and less selected populations than intervention studies, can be complemented by that from these latter studies. Results of this survey showed that, overall, specialists were satisfied with the use of this MD for IBS treatment, as it helps improving symptoms and reduce co-treatments.