Lactiplantibacillus plantarum Lp815 improves sleep and increases urinary GABA in a randomized, double-blind, placebo-controlled study of sleep disturbance.

Participants receiving 5 billion CFU Lp815 exhibited significantly lower insomnia severity index scores at 6 weeks compared to placebo.

• The trial was decentralized, double-blind, randomized, and placebo controlled over 6 weeks.
• 139 individuals were evaluated: Lp815 group n=70, placebo group n=69.
• Participants were screened for at least moderate symptoms of insomnia.
• The difference in insomnia severity index scores was statistically significant (p < 0.05).
• 77.3% of participants in the 5 billion CFU Lp815 cohort exhibited improvement by 4+ points in their insomnia severity index at week 6, compared to 57.8% in the placebo group (p = 0.02).

Anxiety scores were significantly reduced in the Lp815 group compared to placebo, with a more pronounced effect among women.

• Anxiety scores were significantly reduced compared to placebo (p < 0.05).
• The effect was more pronounced among women (p < 0.01).
• The study population was 51.1% female, aged 44 ± 13 years, and 55.4% Caucasian.

Objective measures of sleep duration were increased in the Lp815 cohort compared to placebo.

• Objective sleep data were collected via wearable devices.
• Sleep duration increase was statistically significant compared to placebo (p < 0.05).
• Subjective night sweat severity also decreased in the Lp815 cohort compared to placebo.

The 5 billion CFU Lp815 cohort exhibited an increase in urinary GABA compared to placebo during the first week of use.

• A sub-cohort of n=17 participants submitted a urinary time series for neurotransmitter analysis (Lp815 n=9, placebo n=8).
• The increase in urinary GABA was statistically significant during the first week of use (p < 0.05).
• Urinary GABA was inversely correlated with insomnia scores at week 2 (r2 = -0.30).
• Urinary GABA was inversely correlated with anxiety scores at week 2 (r2 = -0.48).

All adverse events potentially related to product use were mild.

• Safety was assessed across the full study population of 139 individuals.
• No serious adverse events related to product use were reported.
• The dose used was 5 billion CFU of Lp815 per day administered as a capsule.

Lactiplantibacillus plantarum Lp815 was previously demonstrated to improve symptoms of anxiety, motivating investigation of its effects on sleep.

• GABA is described as the major inhibitory neurotransmitter acting through both the central nervous system and via microbial production in the gut.
• Strains able to augment gut GABA production were identified as novel targets for modulation of sleep and mood.
• The current study extended prior anxiety findings to assess sleep, mood, digestion, and objective wearable sleep data over 6 weeks.