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

Minerva Gastroenterol Dietol. 2006 Dec;52(4):349-58.


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 times/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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Abdominal Pain / prevention & control
  • Aged
  • Aged, 80 and over
  • Bifidobacterium*
  • Constipation / diagnosis
  • Constipation / prevention & control
  • Constipation / therapy*
  • Data Interpretation, Statistical
  • Female
  • Humans
  • Intestines / microbiology
  • Irritable Bowel Syndrome / diagnosis
  • Irritable Bowel Syndrome / therapy*
  • Male
  • Oligosaccharides / therapeutic use*
  • Probiotics / therapeutic use*
  • Surveys and Questionnaires
  • Symbiosis
  • Time Factors
  • Treatment Outcome


  • Oligosaccharides