Lactobacillus gasseri LA806 Supplementation in Patients with Irritable Bowel Syndrome: A Multicenter Study

Abstract

The potential benefits of Lactobacillus gasseri LA806 in IBS were previously identified in a comprehensive preclinical research program. The purpose of this multicenter study was to explore in real-life conditions changes in IBS symptoms and quality of life in patients receiving a 4-week supplementation with L. gasseri LA806. Altogether 119 patients meeting Rome IV criteria for IBS were included, of whom 118 received the supplement. The majority of patients (71.8% (95% CI 63.6−79.9%)) manifested a ≥30% decrease in abdominal pain at 4 weeks, the mean abdominal pain score diminishing by 54.2% (from 5.3 ± 2.2 to 2.2 ± 2.4, p < 0.0001). A statistically significant decrease in abdominal pain was seen as early as the first week. A decrease of ≥30% in both abdominal pain score and global IBS symptom score was attained in 61.5% of patients (95% CI 51.7−71.2%). The mean IBS-SSS score fell by 152 ± 112 points (p = 0.001), with symptoms being attenuated in 85% of patients (CGI-I). Supplementation led to a 10-fold decrease in the number of patients reporting severe IBS symptoms. The concomitant intake of antidiarrheals, antispasmodics and analgesics decreased and quality of life scores significantly improved. These preliminary results warrant confirmation by a randomized, placebo-controlled study that this study will allow a better design.

Keywords: abdominal pain; functional disease; irritable bowel syndrome; microbiota; probiotics; quality of life.

Figure 1

Study design. IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale; CGI-I scale, Clinical Global Impression of Improvement scale; SF-12, 12-item Short Form survey (quality of life questionnaire); V, visit; NRS, numeric rating scale.

Figure 2

Flow chart of patient populations. ITT, intention to treat; PP, per protocol; V, visit; IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale.

Figure 3

Week-by-week changes in individual and global (box) IBS symptom intensity scores from inclusion to the end of the 4-week supplementation period (mean ± SEM). Assessed by the patients on numeric rating scales (NRS). * p < 0.05 compared to inclusion; # p < 0.05 compared to week 1; £ p < 0.05 compared to week 2; $ p < 0.05 compared to week 3.

Figure 4

Evolution of IBS severity between inclusion and the end of the 4th week of supplementation. Percentages of patients with IBS rated as severe (IBS-SSS score: [300–500]), moderate (IBS-SSS score: [175–299]), or mild (IBS-SSS score: [75–174]) and percentage of healthy patients (IBS-SSS score: <75, corresponding to remission) at inclusion and after 4 weeks of supplementation. Patient distribution between IBS-SSS classes at 4 weeks differed to a statistically significant extent from that observed at inclusion (p < 0.0001).

Figure 5

Changes in concomitant treatment intake from inclusion to the end of the 4-week supplementation period expressed as the percentage of patients treated at each time point. * p < 0.05 compare to the percentage treated at inclusion; § p = 0.0588.