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Immune effects of Lactobacillus casei Shirota in treated HIV-infected patients with poor CD4+ T-cell recovery.

  • 2020-03-01
  • AIDS (London, England) 34(3)
    • Simone de Barros Tenore
    • Vivian Iida Avelino-Silva
    • Priscilla Ramos Costa
    • Lucas M Franco
    • Ester Cerdeira Sabino
    • Jorge Kalil
    • Natalia Barros Cerqueira
    • Zelinda Nakagawa
    • Esper Georges Kallas

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 48
Population
HIV-infected patients on suppressive ART with poor CD4+ recovery
Methods
Double-blind, placebo-controlled pilot study; daily oral use of Lactobacillus casei Shirota (LcS) for 12 weeks
Blinding
Double-blind
Duration
12 weeks
Funding
Unclear

Background

HIV infection leads to depletion of intestinal CD4+ T cells, mucosal barrier dysfunction, increased gut permeability and microbial translocation even among patients on suppressive ART. Previous studies suggest probiotics may help restore intestinal function.

Methods

In this double-blind, placebo-controlled pilot study, we enrolled HIV-infected patients on suppressive ART with poor CD4+ recovery to address the effect of daily oral use of Lactobacillus casei Shirota (LcS) on CD4+ T-cell count and CD4+/CD8+ ratio at 6 and 12 weeks after treatment initiation; immune activation and intestinal microbiome composition were addressed as secondary outcomes.

Results

From January 2015 to July 2016, 48 patients were randomized (1 : 1) to active intervention or placebo. Groups had comparable demographic and clinical characteristics; only CD4+ T-cell nadir was statistically different between groups. All participants were virologically suppressed under ART. At week 6, the increment in CD4+ T-cell count was 17 cells/μl [interquartile range (IQR) -33 to 74] in the active intervention arm and 4 cells/μl (IQR -43 to 51) in the placebo arm (P = 0.291); at week 12, the change in CD4+ T-cell count was 8 cells//μl (IQR -30 to 70) in the active arm and 10 cells//μl (IQR -50 to 33) among participants allocated to placebo (P = 0.495). Median change in CD4+/CD8+ ratio at week 6 compared with baseline was 0 (IQR -0.04 to 0.05) in the active intervention arm and -0.01 in the placebo arm (IQR -0.06 to 0.03; P = 0.671). At week 12, the change in CD4+/CD8+ ratio was higher in the active product group compared with placebo (respectively 0.07 and 0.01), but this difference failed to reach statistical significance (P = 0.171). We found no significant effects of LcS on immune activation markers, CD4+ and CD8+ subpopulations, sCD14 levels or NK cells at week 12. Finally, we found no statistically significant differences between groups in the change of enteric microbiome at week 12.

Conclusion

In this pilot study, we found no statistically significant effect of LcS probiotic on CD4+ T-cell counts, CD4+/CD8+ ratio, immune activation or intestinal microbiome among HIV-infected patients on suppressive ART with poor CD4+ recovery.

Research Insights

  • Lacticaseibacillus casei→Improved Gut Microbiota Composition

    We found no statistically significant differences between groups in the change of enteric microbiome at week 12.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily oral use
  • Lacticaseibacillus casei→Increased CD4+ T Cell Count

    At week 6, the increment in CD4+ T-cell count was 17 cells/μl ... in the active intervention arm and 4 cells/μl ... in the placebo arm (P = 0.291); at week 12, the change in CD4+ T-cell count was 8 cells//μl ... in the active arm and 10 cells//μl ... among participants allocated to placebo (P = 0.495).

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily oral use
  • Lacticaseibacillus casei→Increased CD4+/CD8+ Ratio

    Median change in CD4+/CD8+ ratio at week 6 compared with baseline was 0 (IQR -0.04 to 0.05) in the active intervention arm and -0.01 in the placebo arm (P = 0.671). At week 12, the change in CD4+/CD8+ ratio was higher in the active product group compared with placebo (respectively 0.07 and 0.01), but this difference failed to reach statistical significance (P = 0.171).

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily oral use
  • Lacticaseibacillus casei→Reduced Immune Activation

    We found no significant effects of LcS on immune activation markers ... at week 12.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily oral use
  • Lacticaseibacillus casei→Reduced sCD14 Level

    We found no significant effects of LcS on ... sCD14 levels ... at week 12.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily oral use
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