Insomnia (moderate)NCT06789718
Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance
An observational study of Insomnia (moderate), run by Verb Biotics LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia (moderate)
- What is being tested?
- GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose) and Optional Sub-Study: Neurotransmitter Urine Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Able to complete study assessments over the course of up to 7 weeks.
Who cannot join
- 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)
Show all 23Show fewer
- 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
- Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
- Presence of any infection or illness that causes chronic night-waking or impairs ability to retain urine overnight (e.g., chronic pain, uncontrolled benign prostatic hyperplasia, prostatitis, urinary tract infection, catheterization, etc.).
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the trial or impact the trial outcomes.
- Known hypersensitivity or previous allergic reaction to microcrystalline cellulose (MCC).
- Presence of another environmental factor that severely impacts sleep quality (e.g., a new baby, pet or other loved one that wakes frequently or needs frequent care or feeding throughout the night)
- Work in an environment requiring shift work (e.g., rotating shifts, night shifts, or irregular hours).
- Have any known and planned international travel during the study period.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Gamma-aminobutyric acid (GABA) is a major inhibitory neurotransmitter in the human nervous system, helping to slow down the stimulation of nerve signals in the brain. GABA plays a pivotal role in calming anxiety, reducing stress and improving sleep. Deficits in GABA levels can lead to a cascade of disorders ranging from anxiety and stress to mood swings and depression. Advancements in understanding the role of the microbiome in the Gut-Brain Axis have highlighted its untapped potential in regulating mood, stress, and sleep via neurotransmitter production.
Several bacterial strains, including lactic acid bacteria, bifidobacteria and others, have demonstrated GABA production capabilities. However, the magnitude of GABA output varies among these strains, and their efficacy in GABA synthesis within the human gastrointestinal environment is uncertain. This stems from the fact that GABA synthesis, typically a pH-stress response, stalls in less acidic environments.
Lactiplantibacillus plantarum Lp815 stands out. Using advanced computational and high-throughput screening techniques, we identified this strain's superior GABA production capability. Remarkably, it synthesizes a significant amount of GABA within the physiologically relevant pH range.
The study will evaluate self-reported sleep disturbance in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys, the use of a health tracking wearable device to explore objective digital outcome measures of sleep, heart rate and heart rate variability and in a subset of participants, the study will utilize an at-home urinary test to evaluate neurotransmitter levels in the body. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and a simple urine test that can be done at home. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.
- Conditions
- Insomnia (moderate)
- Being tested
- GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose), Placebo, Optional Sub-Study: Neurotransmitter Urine Test
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)Dietary supplement
75 participants will be randomized into the study product group.
PlaceboOther
75 participants will be randomized into the placebo group.
Optional Sub-Study: Neurotransmitter Urine TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Optional Sub-Study: Neurotransmitter Urine Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A secondary outcome is to evaluate the impact of GABA Probiotic on anxiety.
This will be measured by a change in Generalized Anxiety Disorder-7 (GAD-7) score between placebo and study product group. Baseline period will be compared as well. On a scale between 0-21, a higher Generalized Anxiety Disorder score indicates more severe anxiety, which is a worse outcome.
Measured: 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
A secondary outcome is to evaluate the impact of GABA Probiotic on gastrointestinal symptoms.
This will be measured by a change in Gastrointestinal Symptom Rating Scale (GSRS) score between placebo and study product group. Baseline period will be compared as well. The Gastrointestinal Symptom Rating Scale uses a 7-point Likert scale, where 1 means no discomfort and 7 means severe discomfort. A higher score indicates more severe gastrointestinal symptoms, which is a worse outcome.
Measured: 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
A secondary outcome is to evaluate the impact of GABA Probiotic on subjective sleep quality.
This will be measured by a change in average sleep quality score as measured by daily 10-point visual analogue rating scale (VAS) between placebo and study product group. Baseline period will be compared as well. A higher score between 0-10, will indicate poor sleep quality and a worse outcome.
Measured: 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
A secondary outcome is to evaluate the impact of GABA Probiotic on daytime alertness.
This will be measured by a change in average daytime alertness score between placebo and study product group as measured by a daily 10-point VAS scale. Baseline period will be compared as well. A higher score between 0-10, will indicate better sleep quality and a better outcome.
Measured: 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
A secondary outcome is to evaluate the impact of GABA Probiotic on mood.
This will be measured by a change in average mood score between placebo and study product group as measured by a daily 10-point VAS scale. Baseline period will be compared as well. A higher score between 0-10, will indicate better mood and a better outcome.
Measured: 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 night sweats
A secondary outcome is to evaluate the impact of GABA Probiotic on night sweats.
This will be measured by a change in average severity score of night sweats between placebo and study product group as measured by a daily 10-point VAS scale. Baseline period will be compared as well. A higher score between 0-10, will indicate severe sweating and a worse outcome.
Measured: 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 quality of life
A secondary outcome is to evaluate the impact of GABA Probiotic on quality of life.
This will be measured by a change in average quality of life score between placebo and study product group as measured by a daily 10-point VAS scale. Baseline period will be compared as well. A higher score between 0-10, will indicate better quality of life and a better outcome.
Measured: 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 improvement in sleep
A secondary outcome is to evaluate the impact of GABA Probiotic on participants' overall subjective impression of improvement in sleep.
This will be measured by a change from baseline in Patient Global Impression of Change (P-GIC) score between placebo and study product group. On a scale between 1-7, a higher score means greater improvement.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start4 Nov 2024
- Primary completion22 Nov 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia (moderate)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verb Biotics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789718
- Sponsor's protocol ID
- PS12
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan currently to share IPD with other researchers.
Publications
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.
PubMed 41554764
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06789718
- Acronym / sponsor ID
- PS12
- Conditions
- Insomnia (moderate)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Verb Biotics LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gamma-aminobutyric acid (GABA) is a major inhibitory neurotransmitter in the human nervous system, helping to slow down the stimulation of nerve signals in the brain. GABA plays a pivotal role in calming anxiety, reducing stress and improving sleep. Deficits in GABA levels can lead to a cascade of disorders ranging from anxiety and stress to mood swings and depression. Advancements in understanding the role of the microbiome in the Gut-Brain Axis have highlighted its untapped potential in regulating mood, stress, and sleep via neurotransmitter production.
Several bacterial strains, including lactic acid bacteria, bifidobacteria and others, have demonstrated GABA production capabilities. However, the magnitude of GABA output varies among these strains, and their efficacy in GABA synthesis within the human gastrointestinal environment is uncertain. This stems from the fact that GABA synthesis, typically a pH-stress response, stalls in less acidic environments.
Lactiplantibacillus plantarum Lp815 stands out. Using advanced computational and high-throughput screening techniques, we identified this strain's superior GABA production capability. Remarkably, it synthesizes a significant amount of GABA within the physiologically relevant pH range.
The study will evaluate self-reported sleep disturbance in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys, the use of a health tracking wearable device to explore objective digital outcome measures of sleep, heart rate and heart rate variability and in a subset of participants, the study will utilize an at-home urinary test to evaluate neurotransmitter levels in the body. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and a simple urine test that can be done at home. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Product | – | Dietary Supplement: GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)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. |
| Placebo | – | Other: PlaceboParticipants 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. |
| Optional Sub-Study: Neurotransmitter Urine Test | – | Diagnostic Test: Optional Sub-Study: Neurotransmitter Urine TestParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (23 listed)
- Do not have a smartphone and/or internet access.
- Concomitant Therapies:
- Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
- Known hypersensitivity or previous allergic reaction to microcrystalline cellulose (MCC).
- Presence of another environmental factor that severely impacts sleep quality (e.g., a new baby, pet or other loved one that wakes frequently or needs frequent care or feeding throughout the night)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose)75 participants will be randomized into the study product group. | Dietary supplement | Study Product |
| Placebo75 participants will be randomized into the placebo group. | Other | Placebo |
| Optional Sub-Study: Neurotransmitter Urine Test20 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. | Diagnostic test | Optional Sub-Study: Neurotransmitter Urine Test |
Primary outcome
Observe differences in sleep outcomes
Time frame: 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.
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.
8 secondary outcomes
Evaluate the impact of GABA Probiotic on anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 night sweats
Time frame: 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 quality of life
Time frame: 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 improvement in sleep
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Derived from this study: PubMed 41554764Grant 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.
- Individual participant dataSharing planned: Undecided. There is no plan currently to share IPD with other researchers.
Related trials for Insomnia (moderate)
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Recruiting
Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
Neoplasm, Sleep Disturbance
Recruiting
Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga
Insomnia, Health Adult Subjects
Not yet recruiting
Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
Mental Distress, Insomnia
Not yet recruiting
Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia (moderate), run by Verb Biotics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe differences in sleep outcomes (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.