Background: Irritable bowel syndrome (IBS) is a chronic disorder with an important impact on patients' quality of life. Although several data indicate that psychological symptoms are frequently reported by patients with IBS, few therapies have been evaluated regarding these issues.
Methods: A retrospective observational study was conducted to evaluate the effectiveness of a probiotic-based dietary supplement (Colicron®) in a group of patients with diarrhea-predominant IBS (IBS-D). We included patients treated with Colicron® (1 cps/day for 8 weeks). Primary endpoint was the gastrointestinal symptoms' remission evaluated by Visual Analogue Scale (VAS); secondary endpoint was the impact of the treatment on physical and mental health evaluated by Hospital Anxiety and Depression Score (HADS) and Short Form Health Survey 36 (SF-36). VAS was assessed at week 4 (T4), week 8 (T8) and week 12 (T12), whereas HADS and SF-36 were performed even at the start of the Colicron® treatment (T0).
Results: An improvement of VAS Score was observed at T8 (P<0.001) and T12 (P<0.05) compared to T4. Lower HADS-A (anxiety subdomain) score was obtained at each time point versus T0 (P<0.01), and higher scores of all SF-36 domains were observed during the treatment (0.05<P<0.001) compared to baseline. Moreover, HADS-D (depression subdomain) score, correlated positively, at T0 (P<0.05) and T4 (P<0.05) with the age, as well as a positive correlation was detected between disease duration (P<0.05) and age of patients (P<0.001).
Conclusions: Colicron® could be useful in improving both gastrointestinal and psychological symptoms in IBS-D patients. Further prospective clinical trials are needed to confirm these preliminary data.