title: I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life.
abstract: OBJECTIVE
  To determine the dose-related effects of a novel probiotic combination, I.31, on irritable bowel syndrome (IBS)-related quality of life (IBS-QoL).
  
  
  METHODS
  A multicenter, randomized, double-blind, placebo-controlled intervention clinical trial with three parallel arms was designed. A total of 84 patients (53 female, 31 male; age range 20-70 years) with IBS and diarrhea according to Rome-III criteria were randomly allocated to receive one capsule a day for 6 wk containing: (1) I.31 high dose (n = 28); (2) I.31 low dose (n = 27); and (3) placebo (n = 29). At baseline, and 3 and 6 wk of treatment, patients filled the IBSQoL, Visceral Sensitivity Index (VSI), and global symptom relief questionnaires.
  
  
  RESULTS
  During treatment, IBS-QoL increased in all groups, but this increment was significantly larger in patients treated with I.31 than in those receiving placebo (P = 0.008). After 6 wk of treatment, IBS-QoL increased by 18 ± 3 and 22 ± 4 points in the high and the low dose groups, respectively (P = 0.041 and P = 0.023 vs placebo), but only 9 ± 3 in the placebo group. Gut-specific anxiety, as measured with VSI, also showed a significantly greater improvement after 6 wk of treatment in patients treated with probiotics (by 10 ± 2 and 14 ± 2 points, high and low dose respectively, P < 0.05 for both vs 7 ± 1 score increment in placebo). Symptom relief showed no significant changes between groups. No adverse drug reactions were reported following the consumption of probiotic or placebo capsules.
  
  
  CONCLUSIONS
  A new combination of three different probiotic bacteria was superior to placebo in improving IBS-related quality of life in patients with IBS and diarrhea.
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Lorenzo-Zúñiga
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Elba
authors.initials: E
authors.lastname: Llop
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Suárez
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Alvarez
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Abreu
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Espadaler
authors.affiliation: Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Serra
mesh_terms: D000328:Adult; D000368:Aged; D003967:Diarrhea / Q000382:microbiology / Q000523:psychology / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007422:Intestines / Q000382:microbiology*; D043183:Irritable Bowel Syndrome / Q000175:diagnosis / Q000382:microbiology / Q000523:psychology / Q000628:therapy*; D048191:Lactiplantibacillus plantarum / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D010376:Pediococcus / Q000502:physiology*; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Irritable bowel syndrome; Probiotic combination; Quality-of-life