A multicenter real-world, open-label study assessing the impact of a probiotic mixture on symptoms of irritable bowel syndrome in adults.

Abstract

Irritable bowel syndrome (IBS) is faced by gastroenterologists daily, and probiotics are a potential therapeutic tool; however, there are no strain recommendations. This multicenter, real-world, single-arm, open-label study aims to assess a novel probiotic mixture's effectiveness, safety, and patient satisfaction in patients with IBS. This study was conducted by 52 Italian gastroenterologists across 16 of the 21 Italian regions who enrolled patients with IBS (n = 1,098). Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lactobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants completed a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2). The primary outcome was the progress of abdominal pain and bloating according with a 5-point Likert scale, (0 absence and 5 highly intense symptoms) and treatment success was defined as a change towards categories of lower IBS severity for abdominal pain and/or bloating. Treatment success for abdominal pain and bloating was achieved in 73% and 81.9% at T1 and 68% and 73.1% at T2, respectively. The probiotic was associated with significantly reducing abdominal pain and bloating at T1 and T2 (P < 0.001). Patients with regular bowel movements increased to 68.5% at T1 and 68.7% at T2, respectively (P < 0.001). Patients reporting that IBS did not affect their daily life increased from 1.8% at entry to 22.7% at T1 and 41.6% at T2 (P < 0.001). This real-world, single-arm, open-label study showed that an 8-week treatment with a novel probiotic mixture is effective, safe, well tolerated, and can improve patients' social lives during and after treatment. Future randomised placebo-controlled studies are necessary to validate these findings. The trial is registered at www.ClinicalTrials.gov (NCT06610149).