Probiotics for Anxiety Study
Key facts
- Who runs it
- Verb Biotics LLC
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 122 people enrolled
- Started
- 4 Mar 2024
- Ended
- 11 Feb 2025
- Type of study
- Observational, 3 groups
- Treatments tested
- GABA Probiotic Dose 1
- GABA Probiotic Dose 2
- Placebo Group
- Record updated
- 14 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
- Do not have a smartphone and/or internet access
Where in United States
- People Science, Inc.Los Angeles, United States
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- GABA Probiotic Dose 1
Dose 1 is a GABA Probiotic containing Lactiplantibacillus plantarum 815 (1 Billion cfu/dose). Capsule taken once daily with food.
- GABA Probiotic Dose 2
Dose 2 is a GABA Probiotic containing Lactiplantibacillus plantarum 815 (5 Billion cfu/dose). Capsule taken once daily with food.
- Placebo Group
Non-active ingredients in the probiotic capsule include organic rice maltodextrin. Capsule taken once daily with food.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 14 November 2024