Probiotics for Anxiety Study

NCT06466603 | Active Not Recruiting

• 1 other identifier: PS08
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• To observe the effect of the 2 different doses of the study product on anxiety

  Change in Generalized Anxiety Disorder-7 (GAD-7) score by 4 points between placebo and study product groups. Baseline period will be compared as well GAD-7 scores between the 2 doses. Scores range from 0 to 21, higher scores indicating a worse outcome.

  7 Weeks

Secondary Outcomes (4)

• To assess the effect of 2 different doses of the study product symptoms of sleep disturbance

  7 Weeks

• To assess the effect of 2 different doses of the study product on sleep quality

  7 Weeks

• To assess the effect of 2 different doses of the study product on quality of life

  7 Weeks

• To assess the effect of 2 different doses of the study product on cognitive ability

  7 Weeks

Study Arms (3)

GABA Probiotic Dose 1

Dose 1 is a GABA Probiotic containing Lactiplantibacillus plantarum 815 (1 Billion cfu/dose). Capsule taken once daily with food.

Dietary Supplement: GABA Probiotic Dose 1

GABA Probiotic Dose 2

Dose 2 is a GABA Probiotic containing Lactiplantibacillus plantarum 815 (5 Billion cfu/dose). Capsule taken once daily with food.

Dietary Supplement: GABA Probiotic Dose 2

Placebo Group

Non-active ingredients in the probiotic capsule include organic rice maltodextrin. Capsule taken once daily with food.

Dietary Supplement: Placebo Group

Interventions

GABA Probiotic Dose 1 DIETARY_SUPPLEMENT

Participants will complete up to a seven week study consisting of screening period, baseline period, up to a 6-week product use period with a total of 42 product use sessions. Screening assessments, baseline questions, product use period questionnaires, adverse event reporting, and end of study experience survey data will be collected. 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. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study.

GABA Probiotic Dose 1

GABA Probiotic Dose 2 DIETARY_SUPPLEMENT

Participants will complete up to a seven week study consisting of screening period, baseline period, up to a 6-week product use period with a total of 42 product use sessions. Screening assessments, baseline questions, product use period questionnaires, adverse event reporting, and end of study experience survey data will be collected. 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. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study.

GABA Probiotic Dose 2

Placebo Group DIETARY_SUPPLEMENT

Participants will complete up to a seven week study consisting of screening period, baseline period, up to a 6-week product use period with a total of 42 product use sessions. Screening assessments, baseline questions, product use period questionnaires, adverse event reporting, and end of study experience survey data will be collected. 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. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size for this study will be approximately 122 healthy volunteers who meet the eligibility criteria.

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

Sponsors & Collaborators

• Verb Biotics LLC: lead
• People Science, Inc.: collaborator

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, Oliver PL, Youssef B, Moos J, Luna V, Craft N. Lactiplantibacillus plantarum Lp815 decreases anxiety in people with mild to moderate anxiety: a direct-to-consumer, randomised, double-blind, placebo-controlled study. Benef Microbes. 2025 Apr 24;16(5):521-532. doi: 10.1163/18762891-bja00073.

  PMID: 40312029 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

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: June 13, 2024
• First Posted: June 20, 2024
• Study Start: March 4, 2024
• Primary Completion: June 11, 2024
• Study Completion: February 11, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)