I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life

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; Quality-of-life.

Figures

Figure 1

Patient flow through the study according to CONSORT guidelines[37]. Note the similar number of loss to follow-up in all treatment arms. IBSQoL: Irritable bowel syndrome-related quality of life; VSI: Visceral Sensitivity Index.

Figure 2

Irritable bowel syndrome related quality of life score improvement compared to baseline after 42 d of treatment. A: Global scores improved significantly more in both treatment groups than placebo (Kruskall-Wallis test); B: Among the different domains, the mental status showed a significant improvement when compared to placebo.

Figure 3

Irritable bowel syndrome-related quality of life score response to probiotic and placebo therapy. Good response was defined as score improvement ≥ 15 points; poor response as score improvement 10-15 points; and non-response as score improvement 10) was significantly larger in both groups of patients treated with probiotics than in those treated with placebo (χ2 test). IBSQoL: Irritable bowel syndrome-related quality of life.