Exploratory Analysis of Pruritus and Sleep Outcomes After LCR35 Supplementation in Maintenance Hemodialysis: A Randomized, Open-Label Controlled Study.

BACKGROUND/

OBJECTIVES

Uremic pruritus and sleep disturbance commonly coexist in patients receiving maintenance hemodialysis. This analysis examined whether supplementation with Lactobacillus casei var. rhamnosus LCR35 was associated with changes in pruritus and sleep outcomes.

METHODS

This 12-week randomized, open-label, controlled study included 78 patients receiving maintenance hemodialysis who were assigned to LCR35 supplementation (n = 38; three sachets daily) or usual care without probiotic supplementation (n = 40). No placebo was used. Outcomes were Pittsburgh Sleep Quality Index (PSQI) and 5-D Itch Scale results. We used analysis of covariance (ANCOVA) for between-group analyses, with the week-12 score as the dependent variable and the corresponding baseline score as a covariate.

RESULTS

In the LCR35 group, descriptive improvements were observed in the 5-D Itch Scale and selected PSQI outcomes. However, none of the baseline-adjusted between-group differences was statistically significant: for 5-D Itch Scale, -1.48 (95% confidence interval (CI), -3.64 to 0.68; p = 0.176); for global PSQI, -0.80 (95% CI, -2.09 to 0.50; p = 0.225); for PSQI sleep disturbance, -0.07 (95% CI, -0.27 to 0.13; p = 0.482); and use of sleep medications, -0.28 (95% CI, -0.67 to 0.12; p = 0.163). In the LCR35 group, the exploratory association between changes in pruritus and the PSQI sleep-disturbances component was significant before, but not after, false-discovery-rate (FDR) correction (p = 0.007; FDR q = 0.055).

CONCLUSIONS

Our preliminary findings raised the possibility that LCR35 might modestly influence pruritus and specific sleep disturbances. However, our results do not firmly establish a treatment effect, nor a patient phenotype most likely to benefit.