509 Burden of IBS-Diarrhea Symptoms Tracked With Daily Journals for 12 Weeks in a Randomized, Double-Blind, Placebo-Controlled Study of Lactobacillus AcidophilusCL1285, L. Casei LBC80R and L. Rhamnosus CLR2

INTRODUCTION: The burden of symptoms in Irritable Bowel Syndrome is chronic and fluctuates from day to day, yet most research studies rely on scheduled clinical interviews. Daily symptom journals may provide better precision of the burden of illness. The diarrhea-predominant presentation of IBS (IBS-D) is particularly disruptive to Quality of Life. METHODS: Subjects with a history of IBS were randomized, double-blind, to oral capsules of a probiotic comprised of Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2, 100 billion CFU daily, or placebo in a 2:1 ratio (Preston 2018). In addition to the clinical interviews, subjects kept daily records of each stool with the Bristol Stool Scale (BSS), and, scored their abdominal pain on a 10-point visual analog scale (VAS). Scores were pooled for weeks 1 through 6 and weeks 7-12. Liquid stools had BSS ratings of 6 or 7. Missing journal entries were imputed with the Last Observation Carried Forward. A regression was performed for IBS-related Quality of Life scores at clinical interviews and journal data for abdominal pain and the proportion of liquid stools. RESULTS: Daily journals were available for 38 subjects with IBS-D (N = 26, active, N = 12, placebo). The active treatment group had significantly more liquid stools at baseline relative to placebo, RR = 1.2, P < 0.001. Both groups decreased vs. baseline for weeks 1-6 but the ratio remained the same, RR = 1.2, P < 0.001. For weeks 7-12 the number of liquid stools for placebo plateaued but the active group continued to improve, RR = 0.7, P < 0.001. The number of days of abdominal pain, 6 or greater on the VAS, in each arm was similar at baseline, RR = 0.9, but there were significantly fewer days of pain with probiotic treatment vs. placebo for weeks 1-6 and 7-12, RR = 0.6, 0.5, respectively, P < 0.001. For weeks 7-12, the probiotic group experienced fewer weeks with any pain rating of 6 or greater, RR = 0.6, P = 0.02. Better Quality of Life was correlated with fewer days of abdominal pain, 3 or greater on the VAS, and, a lower proportion of liquid stools (R 2 = 0.16, P < 0.001). CONCLUSION: There was an important decrease in the burden of IBS-D symptoms in both treatment arms. Compared to placebo, subjects taking the probiotic capsules had fewer liquid stools and fewer days of abdominal pain. Despite variability among the subjects with IBS-D, fewer days of pain and a lower proportion of liquid stools correlated with improved IBS-related Quality of Life. Preston K, et al. Beneficial Microbes , 2018, 9(5):697-706.