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NCT06789718 · ClinicalTrials.gov registry record
Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance
A clinical trial of Insomnia (moderate), sponsored by Verb Biotics.
- Active
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT06789718: Active study of Insomnia (moderate), sponsored by Verb Biotics.
NCT06789718 is a study of Insomnia (moderate) that is active but no longer recruiting, run by Verb Biotics. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06789718, a study of Insomnia (moderate), is active but no longer recruiting, sponsored by Verb Biotics.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome is to observe differences in sleep outcomes between the GABA Probiotic and the placebo control group from intake and baseline to the end of the study period. This will be measured by a change in the Insomnia Sleep Index (ISI) score between placebo and study product group. Baseline period will be compared as well. On a scale of 0-28, a higher score indicates more severe insomnia, which is a worse outcome.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)
- DIAGNOSTIC_TEST Optional Sub-Study: Neurotransmitter Urine Test
Study Locations (1)
California
- People Science, Inc. - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2025-03-01 |
What the registry record for NCT06789718 still lists
NCT06789718 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Insomnia (moderate) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06789718 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06789718 about?
NCT06789718 is a clinical study titled "Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance". 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, da...
What is the current status of trial NCT06789718?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2024-11-04. Estimated completion is 2025-03-01.
What conditions does trial NCT06789718 study?
This clinical trial studies the following conditions: Insomnia (moderate).
What interventions are being tested in trial NCT06789718?
The interventions under investigation include: Placebo (OTHER), GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose) (DIETARY_SUPPLEMENT), Optional Sub-Study: Neurotransmitter Urine Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06789718?
This trial is sponsored by Verb Biotics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06789718 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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