Randomized Clinical Trial
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World J Gastroenterol. Jul 14, 2014; 20(26): 8709-8716
Published online Jul 14, 2014. doi: 10.3748/wjg.v20.i26.8709
I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life
Vicente Lorenzo-Zúñiga, Elba Llop, Cristina Suárez, Beatriz Álvarez, Luis Abreu, Jordi Espadaler, Jordi Serra
Vicente Lorenzo-Zúñiga, Jordi Serra, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, 08916 Badalona, Spain
Elba Llop, Cristina Suárez, Beatriz Álvarez, Luis Abreu, Gastroenterology, Hospital Puerta de Hierro, 28222 Madrid, Spain
Jordi Espadaler, AB-Biotics, 08916 Badalona, Spain
Author contributions: All authors contributed equally to this paper.
Supported by Spanish Ministry of Health, Instituto de Salud Carlos III (in part), No. PI10/02135
Correspondence to: Jordi Serra, MD, PhD, Gastroenterology, Motility and Functional Gut Disorders Unit, Hospital Universitari Germans Trias i Pujol/CIBERehd, Carretera del Canyet s/n, 08916 Badalona, Spain. jserrap.germanstrias@gencat.cat
Telephone: +34-93-4978866  Fax: +34-93-4978866
Received: November 6, 2013
Revised: February 5, 2014
Accepted: March 19, 2014
Published online: July 14, 2014
Abstract

AIM: 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.

CONCLUSION: 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.

Keywords: Irritable bowel syndrome, Probiotic combination, Irritable bowel syndrome, Quality-of-life

Core tip: Irritable bowel syndrome (IBS) is a benign functional gut disorder, and its severity is closely related to the impact of the disorder on quality of life. Probiotic bacteria have been shown to have a modest beneficial effect on abdominal symptoms in patients with IBS, but the effect of probiotics on IBS-related quality of life (IBS-QoL) is unclear. The present study was designed to specifically address the effect of a probiotic combination (I.31) on IBS-QoL, and demonstrates that I.31 is superior to placebo in improving IBS-QoL. These data suggest that I.31 may be beneficial for the global management of this complex disorder.