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

NCT06789718 | Active Not Recruiting

• 1 other identifier: PS12
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Observe differences in sleep outcomes

  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.

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

Secondary Outcomes (8)

• Evaluate the impact of GABA Probiotic on anxiety

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

• Evaluate the impact of GABA Probiotic on gastrointestinal symptoms

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

• Evaluate the impact of GABA Probiotic on subjective sleep quality

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

• Evaluate the impact of GABA Probiotic on daytime alertness

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

• Evaluate the impact of GABA Probiotic on mood

  Participants will complete up to a 16-week study consisting of screening period, randomization and shipping period, a baseline period, and a 6-week product/placebo use period.

Study Arms (3)

Study Product

Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study product will contain the GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose) and Microcrystalline Methylcellulose.

Dietary Supplement: GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)

Placebo

Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study placebo will only contain Microcrystalline Methylcellulose.

Other: Placebo

Optional Sub-Study: Neurotransmitter Urine Test

Participants who meet the study eligibility criteria and who opt-in to the sub-study will be given the Optional Sub-Study Informed Consent Form and be asked to complete neurotransmitter urine tests during baseline, day 2, day 4, day 7, day 14, day 28, and day 42 in parallel with the main study requirements. The cap for entering the sub-study will be 20 participants out of the 150 on a first-come first-serve basis.

Diagnostic Test: Optional Sub-Study: Neurotransmitter Urine Test

Interventions

GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose) DIETARY_SUPPLEMENT

75 participants will be randomized into the study product group.

Study Product

Placebo OTHER

75 participants will be randomized into the placebo group.

Placebo

Optional Sub-Study: Neurotransmitter Urine Test DIAGNOSTIC_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.

Optional Sub-Study: Neurotransmitter Urine Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Generally healthy participants (all genders) 18 years or older who have self-reported sleep disturbance with a score of \>15 on the screening Insomnia Severity Index questionnaire.

You may qualify if:

• Age \> 18 years old
• Has self-reported sleep disturbance
• Insomnia Severity Index (ISI) score of \> 15, with score on question on difficulty falling asleep \> 2 ("moderate") at screening
• Interested in understanding more about their sleep and choose to use the probiotic product
• Willing to do a 1-week washout out of any OTC or other products for sleep and/or (e.g. melatonin, anticholinergics, valerian root etc.) prior to randomization and refrain from use for the duration of the study
• Willing to do a 4-week washout from any systemic antibiotic, prebiotic, probiotic and postbiotic use prior to randomization
• If taking prescription medications for sleep and/or anxiety (e.g. Benzodiazepines, zolpidem, zaleplon, SSRIs, Buspirone, Tricyclics, MAOIs), or other class of medication for sleep, must be on a "stable dose" for at least 4 weeks prior to randomization. "Stable dose" is defined as no changes in dosage or frequency of the specified medications for at least 4 weeks prior to randomization and throughout the study period.
• If using any cannabis-containing products, must be on a stable dose for at least 4 weeks prior to randomization and consume \< 10 mg/day of THC
• If regularly consuming alcohol, must be willing to stay on a stable amount throughout the study period and to log alcohol consumption.
• In good general health at the time of screening (Investigator discretion).
• Able to read and understand English.
• Able to read, understand, and provide informed consent.
• Able to use a personal smartphone device and download Chloe by People Science.
• Able to receive shipment of the product at an address within the United States.
• Is willing to wear, sync daily, and charge twice weekly a provisioned health tracking wearable device (Oura ring) everyday (up to 7 weeks) during sleep. If the participant already has an Oura ring, they can use their own device and account.

You may not qualify if:

• Do not have a smartphone and/or internet access.
• Concomitant Therapies:
• Participants taking prescription medication for sleep and/or anxiety (e.g. Benzodiazepines, zolpidem, zaleplon, SSRIs, Buspirone, Tricyclics, MAOIs) not on a stable dose for at least 4 weeks
• Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
• Participants taking any other prescription medications that impact systemic GABA levels (e.g., GABA supplements, barbiturates, gabapentin, pregabalin, valproate, tiagabine, vigabatrin, baclofen)
• Participants currently taking or have taken probiotics, prebiotics or postbiotics within the past 4 weeks prior to randomization.
• Current antibiotic use or use within 4 weeks prior to randomization.
• Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
• Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
• Confirmed diagnosis of Sleep Apnea that is untreated or not well controlled
• Known diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) or Irritable Bowel Syndrome
• Current or prior history of psychotic disorder
• Confirmed diagnosis of major depressive disorder or bipolar disorder
• Diagnosed with Alcohol or Substance Abuse Disorder

Sponsors & Collaborators

• Verb Biotics LLC: lead

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90034, United States

Location

Related Publications (1)

• Grant AD, Erfe MCB, Delebecque CJ, Keller D, Zimmerman NP, Kazaryan A, Oliver PL, Moos J, Luna V, Craft N. Lactiplantibacillus plantarum Lp815 improves sleep and increases urinary GABA in a randomized, double-blind, placebo-controlled study of sleep disturbance. Sci Rep. 2026 Jan 19;16(1):644. doi: 10.1038/s41598-025-27861-6.

  PMID: 41554764 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Up to 20 participants (10 per study group) will be consented to participate in an optional substudy that involves collection of urine using a neurotransmitter urine-test at home at 7 timepoints during study period (Baseline, Day 9, 12, 14, 21, 35, and 49 during the study product use period).

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Noah Craft, MD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: November 4, 2024
• Primary Completion: November 22, 2024
• Study Completion: March 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)