NCT06789718

Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance

A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled Study Assessing the Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Verb Biotics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale for this study is to observe differences in sleep outcomes between a consumer-grade probiotic capsule called GABA Probiotic and a placebo control group. Additionally, the study aims to evaluate the impact of the probiotic product on anxiety, gastrointestinal symptoms, sleep quality, daytime alertness, mood, stress, severity of night sweats (if present), and quality of life. In a subset of participants, the study also aims to evaluate how the probiotic affects neurotransmitter levels in the body using an at-home urinary test. A consumer-driven, decentralized observational clinical research study is therefore well-suited for evaluating the impact of this probiotic product in this population.

Detailed description

Gamma-aminobutyric acid (GABA) is a major inhibitory neurotransmitter in the human nervous system, helping to slow down the stimulation of nerve signals in the brain. GABA plays a pivotal role in calming anxiety, reducing stress and improving sleep. Deficits in GABA levels can lead to a cascade of disorders ranging from anxiety and stress to mood swings and depression. Advancements in understanding the role of the microbiome in the Gut-Brain Axis have highlighted its untapped potential in regulating mood, stress, and sleep via neurotransmitter production. Several bacterial strains, including lactic acid bacteria, bifidobacteria and others, have demonstrated GABA production capabilities. However, the magnitude of GABA output varies among these strains, and their efficacy in GABA synthesis within the human gastrointestinal environment is uncertain. This stems from the fact that GABA synthesis, typically a pH-stress response, stalls in less acidic environments. Lactiplantibacillus plantarum Lp815 stands out. Using advanced computational and high-throughput screening techniques, we identified this strain's superior GABA production capability. Remarkably, it synthesizes a significant amount of GABA within the physiologically relevant pH range. The study will evaluate self-reported sleep disturbance in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys, the use of a health tracking wearable device to explore objective digital outcome measures of sleep, heart rate and heart rate variability and in a subset of participants, the study will utilize an at-home urinary test to evaluate neurotransmitter levels in the body. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and a simple urine test that can be done at home. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.

Conditions

• Insomnia (moderate)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)	75 participants will be randomized into the study product group.
OTHER	Placebo	75 participants will be randomized into the placebo group.
DIAGNOSTIC_TEST	Optional Sub-Study: Neurotransmitter Urine Test	20 participants who opt-in to the sub-study will provide urine tests during baseline, day 2, day 4, day 7, day 14, day 28, and day 42 while simultaneously participating in the main-study.

Timeline

• Start date: 2024-11-04
• Primary completion: 2024-11-22
• Completion: 2025-03-01
• First posted: 2025-01-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: United States