Clinical Trial

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

Active, Not Recruiting
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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.
Trial Details
NCT Number NCT06789718
Lead Sponsor Verb Biotics LLC
Conditions Insomnia (moderate)
Enrollment 150 participants
Start Date 2024-11-04
Primary Completion 2024-11-22 (estimated)
Study Completion 2025-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-23