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Efficacy and Safety of Lactobacillus acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea: A Randomized, Placebo-Controlled Study.

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 82
Population
82 adult participants receiving amoxicillin treatment
Methods
randomized, double-blind, placebo-controlled trial; participants were randomized to receive either LA85 (2 × 10^9 CFU/day) or placebo for 14 days
Antibiotic-associated diarrhea (AAD) is a common clinical complication resulting from antibiotic-induced gut microbiota dysbiosis. Lactobacillus acidophilus LA85, a probiotic strain illustrated with in vitro antimicrobial and immunomodulatory properties, may offer a preventive approach against AAD. However, clinical evidence on its efficacy remains limited. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of L. acidophilus LA85 in preventing amoxicillin-associated diarrhea. A total of 82 adult participants receiving amoxicillin treatment were randomized to receive either LA85 (2 × 109 CFU/day) or placebo for 14 days. The primary outcomes included AAD incidence, diarrhea duration, and stool consistency, while secondary outcomes assessed gastrointestinal quality of life and safety. LA85 supplementation was associated with a trend toward a reduction in the incidence of AAD; however, this difference did not reach statistical significance. Nonetheless, LA85 notably shortened the duration of diarrhea episodes compared to placebo (p = 0.072), suggesting a clinically meaningful improvement. Participants receiving LA85 exhibited less variability in stool consistency scores, assessed by the Bristol stool form scale (BSFS), maintaining scores consistently around 3.5. In contrast, placebo recipients had greater fluctuations between 3.5 and 4.0, indicating less stable stool consistency during antibiotic treatment. Importantly, exploratory subgroup analysis revealed that in younger participants (< 53 years age), LA85 supplementation significantly reduced the incidence of AAD (p = 0.008) and effectively eliminated persistent diarrhea episodes. Gastrointestinal quality of life scores improved significantly in the probiotic group (p < 0.05). No serious adverse events were reported, supporting the safety of LA85. While these findings support the clinical application of LA85 for preventing AAD, further large-scale trials incorporating microbiome analysis and longer follow-up periods are necessary to confirm its long-term benefits and generalizability. Trial Registration: This clinical trial (ClinicalTrials.gov Identifier: NCT05974657) was registered on August 3, 2023.

Research Insights

  • Lactobacillus acidophilus LA85→Improved Quality of Life

    Gastrointestinal quality of life scores improved significantly in the probiotic group (p<0.05).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2×10^9 CFU/day
  • Lactobacillus acidophilus LA85→Improved Stool Consistency

    Participants receiving LA85 exhibited less variability in stool consistency scores, assessed by the Bristol stool form scale (BSFS), maintaining scores consistently around 3.5. In contrast, placebo recipients had greater fluctuations between 3.5 and 4.0, indicating less stable stool consistency during antibiotic treatment.

    Effect
    Neutral
    Effect size
    Small
    Dose
    2×10^9 CFU/day
  • Lactobacillus acidophilus LA85→Reduced Antibiotic-Associated Diarrhea

    Exploratory subgroup analysis revealed that in younger participants (<53 years age), LA85 supplementation significantly reduced the incidence of AAD (p=0.008) and effectively eliminated persistent diarrhea episodes.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    2×10^9 CFU/day
  • Lactobacillus acidophilus LA85→Reduced Diarrhea Rate

    Exploratory subgroup analysis revealed that in younger participants (<53 years age), LA85 supplementation significantly reduced the incidence of AAD (p=0.008) and effectively eliminated persistent diarrhea episodes.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    2×10^9 CFU/day
  • Lactobacillus acidophilus LA85→Reduced Duration of Diarrhea

    LA85 notably shortened the duration of diarrhea episodes compared to placebo (p=0.072), suggesting a clinically meaningful improvement.

    Effect
    Neutral
    Effect size
    Small
    Dose
    2×10^9 CFU/day
  • Lactobacillus acidophilus LA85→Reduced Incidence of Antibiotic-Associated Diarrhea

    In younger participants (< 53 years age), LA85 supplementation significantly reduced the incidence of AAD (p = 0.008) and effectively eliminated persistent diarrhea episodes.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    2×10^9 CFU/day

Adverse Events Reported

  • Lactobacillus acidophilus LA85→serious adverse events

    No serious adverse events were reported, supporting the safety of LA85.

    Finding
    No significant difference
    Severity
    Serious adverse event
  • Lactobacillus acidophilus LA85→Overall tolerability

    No serious adverse events were reported, supporting the safety of LA85.

    Finding
    Reported
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