title: A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life.
abstract: OBJECTIVE
  The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria.
  
  
  BACKGROUND
  There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS.
  
  
  METHODS
  This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.
  
  
  RESULTS
  Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group.
  
  
  CONCLUSIONS
  This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.
authors.affiliation: Chirurgia Generale e Geriatrica, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli Federico II, Via Pansini 5, 80131 Napoli, Italy. carmi_c@hotmail.it
authors.forename: Carmelina
authors.initials: C
authors.lastname: Cappello
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Tremolaterra
authors.forename: Annalisa
authors.initials: A
authors.lastname: Pascariello
authors.forename: Carolina
authors.initials: C
authors.lastname: Ciacci
authors.forename: Paola
authors.initials: P
authors.lastname: Iovino
mesh_terms: D015746:Abdominal Pain / Q000150:complications; D000328:Adult; D003710:Demography; D004032:Diet; D005260:Female; D005414:Flatulence / Q000150:complications; D005772:Gastrointestinal Transit / Q000187:drug effects; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology*; D008297:Male; D055118:Medication Adherence; D010147:Pain Measurement; D019936:Probiotics / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life; D013559:Symbiosis