Probiotics for Anxiety Study

Running, not enrolling · Has a placebo group

Conditions studied: Anxiety

In brief

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.

Key facts

Study ID

NCT06466603

Run by

Verb Biotics LLC

People needed

122

Starts

2024-03-04

Expected to finish

2025-02-11

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• People Science, Inc. — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.