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

NCT06789718 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Insomnia (moderate)

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.

Sponsors & Collaborators

  • Verb Biotics LLC

    lead INDUSTRY

Principal Investigators

  • Noah Craft, MD · People Science, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2024-11-22
Completion
2025-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789718 on ClinicalTrials.gov