Supplements

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).

2 min readUpdated Aug 28, 20261 RCTsView structured evidence →
Evidence Score48/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★
Confidencelow

This article is automatically generated from the structured evidence profile behind the claim above. Scores reflect the quality and quantity of available research, not clinical advice.

LCR35 supplementation does not significantly improve pruritus or sleep outcomes in maintenance hemodialysis patients The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 48/100 (low).

The Claim

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

This conclusion is most relevant to: Patients receiving maintenance hemodialysis (n=78).

What the Research Shows

The conclusion draws on 1 linked study. Highlights from the cited literature:

  • Exploratory Analysis of Pruritus and Sleep Outcomes After LCR35 Supplementation in Maintenance Hemodialysis: A Randomized, Open-Label Controlled Study. (Life (Basel, Switzerland), 2026) — 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).

How It Works

The proposed biological pathway:

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

Who Might Benefit

Evidence fit by population:

  • Patients receiving maintenance hemodialysis (n=78)

Limitations & Caveats

Important context when interpreting this evidence:

  • 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.

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 article is auto-generated from structured research data 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.