Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant: Results of an open, uncontrolled multicenter study

Aim. Irritable bowel syndrome (IBS) is frequently associated with an imbalance in intestinal bacteria. To date, few studies have evaluated the efficacy and safety of probiotic administration in patients with constipation-variant IBS. A new agent recently available in clinical practice is a symbiotic consisting of a probiotic, Bifidobacterium longum W11, and the short chain oligosaccharide prebiotic Fos Actilight. The aim of this study was to evaluate the efficacy and safety of this symbiotic in patients with constipation-variant IBS. Methods. A total of 636 patients (250 men, 386 women) diagnosed with constipation-type IBS according to the Roma II criteria were enrolled in 43 centers and received the symbiotic at a dose of 3 g/die for at least 36 days. A validated questionnaire investigating symptoms and stool frequency was administered before and after treatment. Results. Based on patient responses to visual scale items, frequency increased significantly after treatment in the "no symptom" class from 3% to 26.7% for bloating and from 8.4% to 44.1% for abdominal pain (P<0.0001). In the more severe symptoms classes (moderate-severe), symptom frequency dropped significantly from 62.9% to 9.6% and from 38.8% to 4.1% for bloating and abdominal pain, respectively. Stool frequency significantly increased from 2.9±1.6 tunes/week to 4.1±1.6 times/week. Conclusions. The study product can increase stool frequency in patients with constipation-variant IBS and reduce abdominal pain and bloating in those with moderate-severe symptoms.