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LCR35 supplementation does not significantly improve pruritus or sleep outcomes in maintenance hemodialysis patients

In a 12-week randomized, open-label controlled study of 78 maintenance hemodialysis patients, LCR35 supplementation (three sachets daily) showed descriptive improvements in pruritus (5-D Itch Scale) and selected sleep outcomes (PSQI), but none of the baseline-adjusted between-group differences were statistically significant. For example, the 5-D Itch Scale difference was -1.48 (95% CI, -3.64 to 0.68; p = 0.176) and global PSQI difference was -0.80 (95% CI, -2.09 to 0.50; p = 0.225).

Last updated: Aug 28, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score48/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Exploratory Analysis of Pruritus and Sleep Outcomes After LCR35 Supplementation in Maintenance Hemodialysis: A Randomized, Open-Label Controlled Study.

rct

Hung KC, Liao MT, Zheng CM, Chen SF, Lu LT, Chao CT, Lu KC · Life (Basel, Switzerland) (2026)

Participants: 78
Duration: 12 weeks
Intervention: Lactobacillus casei var. rhamnosus LCR35 supplementation (three sachets daily) for 12 weeks
Outcome: Pruritus (5-D Itch Scale) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) including global score, sleep disturbance, and use of sleep medications
Effect Size: N/A (no significant effects; reported differences: 5-D Itch Scale -1.48, global PSQI -0.80, PSQI sleep disturbance -0.07, sleep medications -0.28)
Population: Patients receiving maintenance hemodialysis (n=78)

Result: In a 12-week randomized, open-label controlled study of 78 maintenance hemodialysis patients, LCR35 supplementation (three sachets daily) showed descriptive improvements in pruritus (5-D Itch Scale) and selected sleep outcomes (PSQI), but none of the baseline-adjusted between-group differences were statistically significant. For example, the 5-D Itch Scale difference was -1.48 (95% CI, -3.64 to 0.68; p = 0.176) and global PSQI difference was -0.80 (95% CI, -2.09 to 0.50; p = 0.225).

PubMed: 42652979DOI: 10.3390/life16081291

Mechanism Graph

LCR35 supplementation may modulate gut microbiota or immune responses
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Potential reduction in uremic pruritus via anti-inflammatory or antipruritic pathways
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Possible improvement in sleep disturbances through reduced itching
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Observed exploratory association between pruritus changes and PSQI sleep-disturbance component (p=0.007, FDR q=0.055) but not significant after correction

Limitations

  • ⚠Open-label design without placebo, increasing risk of bias
  • ⚠No statistically significant between-group differences, so findings are preliminary and not conclusive
  • ⚠Exploratory analysis with multiple comparisons; association lost significance after FDR correction
  • ⚠Small sample size (n=78) may limit power to detect modest effects

Frequently Asked Questions

Does LCR35 improve pruritus in hemodialysis patients?▼

The study found descriptive improvements in the 5-D Itch Scale with LCR35, but the difference was not statistically significant (p=0.176), so no firm conclusion can be drawn.

Does LCR35 improve sleep quality in hemodialysis patients?▼

No significant improvement was observed in global PSQI or specific sleep components (e.g., sleep disturbance, sleep medication use) after 12 weeks of LCR35 supplementation.

What was the study design?▼

It was a 12-week randomized, open-label, controlled study with 78 maintenance hemodialysis patients, comparing LCR35 supplementation (n=38) to usual care without probiotic (n=40). No placebo was used.

Is LCR35 recommended for sleep or itch in hemodialysis?▼

No, the results do not support a firm treatment effect. The authors note that findings are preliminary and do not establish a benefit or identify a patient phenotype most likely to benefit.

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References

  1. 1.Hung KC, Liao MT, Zheng CM, Chen SF, Lu LT, Chao CT, Lu KC. "Exploratory Analysis of Pruritus and Sleep Outcomes After LCR35 Supplementation in Maintenance Hemodialysis: A Randomized, Open-Label Controlled Study.." Life (Basel, Switzerland), 2026. PMID: 42652979 DOI: 10.3390/life16081291
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.