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ACTIVE NOT RECRUITING
NCT06789718

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

Sponsor: Verb Biotics LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-11-04

Completion Date

2025-03-01

Last Updated

2025-01-23

Healthy Volunteers

No

Interventions

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.

Locations (1)

People Science, Inc.

Los Angeles, California, United States