Clinical trial NCT06466603: Probiotics for Anxiety Study
Official title: A Randomized, Double-blind, Placebo-controlled Study with Open-Label Extension Investigating the Effects of 2 Different Doses of GABA Probiotic Lp815 on Anxiety in Individuals with Mild to Moderate Anxiety in a Home Setting
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anxiety
Keywords: Generalized Anxiety Disorder
Lead sponsor: Verb Biotics LLC
Sponsor class: INDUSTRY
Collaborators: name: People Science, Inc.
First posted: 2024-06-20
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size for this study will be approximately 122 healthy volunteers who meet the eligibility criteria.

Brief summary: The purpose of this study is to observe the effect of a consumer-grade probiotic capsule called GABA (gamma-aminobutyric acid ) Probiotic ("Study Product"), a probiotic capsule containing Lactiplantibacillus plantarum 815, on anxiety. The purpose of this study is to evaluate the effects of 2 different doses of this probiotic study product on anxiety in comparison to placebo. Additionally, the study aims to observe the effects of the probiotic study product on mood, cognitive function, quality of life and sleep. After the 6-week study product use period, all participants will be given the option to continue using GABA Probiotic for an additional 4 weeks.

Participants in this study will complete surveys and questionnaires about their experience before, during and after taking the study product. Additionally, this study will incorporate the use of a wrist-worn electronic device to measure sleep.

Detailed description: This study aims to observe the effect of Lactiplantibacillus plantarum VDL815 formulated into a probiotic capsule in individuals with mild to moderate anxiety to serve as a pilot exploration of potential health benefits and dosing. Participants will complete up to a 16-week study consisting of a screening period, randomization and shipping period, a baseline period, a 6-week product/placebo use period and an optional 4-week open label extension.

The rationale for this study is to observe the effect of 2 different doses of a consumer-grade probiotic capsule called GABA Probiotic on anxiety in individuals with mild to moderate anxiety. Additionally, the study aims to observe the effects of the probiotic product on mood, cognition, quality of life, and sleep disturbance. A consumer-driven, decentralized observational clinical research study is well-suited for examining the effect of this probiotic on anxiety.

Anxiety is highly prevalent and impacted by many interdependent variables. We will examine self-reported anxiety in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and the use of a health tracking wearable device to explore objective digital outcome measures of sleep and heart rate variability. 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. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Has self-reported mild to moderate generalized anxiety
* Generalized Anxiety Disorder-7 (GAD-7) score of 5-14 at screening
* Interested in understanding more about their anxiety and the use probiotic products
* If taking any OTC or other products for anxiety and/or sleep (e.g. magnesium, melatonin, anticholinergics etc.), must be on a stable dose for at least 4 weeks prior to randomization and maintain the stable intake for the duration of the study.
* Willing to do a 4-week washout from any systemic antibiotic use prior to randomization.
* If using any cannabis-containing products, must be on a stable dose for at least 4 weeks prior to randomization.
* 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.
* Willing to wear a health tracking wearable device everyday (up to 7 weeks) during sleep.
* Able to complete study assessments over the course of up to 7 weeks.

Exclusion Criteria:

* Do not have a smartphone and/or internet access.
* Concomitant Therapies:

  * Participants taking prescription medication for anxiety and/or sleep
  * Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
* Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:

  * Known diagnosis of Generalized Anxiety Disorder that is uncontrolled and severe
  * Known diagnosis of Inflammatory Bowel Disease
  * Known diagnoses of the following disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders, Panic Disorder
  * Current or prior psychotic disorder

Primary outcomes:
measure: To observe the effect of the 2 different doses of the study product on anxiety
timeFrame: 7 Weeks
Secondary outcomes:
measure: To assess the effect of 2 different doses of the study product symptoms of sleep disturbance
timeFrame: 7 Weeks
measure: To assess the effect of 2 different doses of the study product on sleep quality
timeFrame: 7 Weeks
measure: To assess the effect of 2 different doses of the study product on quality of life
timeFrame: 7 Weeks
measure: To assess the effect of 2 different doses of the study product on cognitive ability
timeFrame: 7 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: People Science, Inc.
state: California
Study officials:
affiliation: People Science, Inc.
name: Noah Craft, MD
role: PRINCIPAL_INVESTIGATOR
References: