Probiotics for Anxiety Study

Anxiety Clinical Trial

Official title:

A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled Study With Open-Label Extension Investigating the Effects of 2 Different Doses of GABA Probiotic Lactiplantibacillus Plantarum 815 on Anxiety in Individuals With Mild to Moderate Anxiety in a Home Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06466603
• Other study ID #: PS08
• Status: Active, not recruiting
• Start date: March 4, 2024
• Est. completion date: February 11, 2025

Study information

• Verified date: June 2024
• Source: Verb Biotics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: February 11, 2025
• Est. primary completion date: June 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Dietary Supplement:
• GABA Probiotic Dose 1
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
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
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.

Locations

Country	Name	City	State
United States	People Science, Inc.	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Verb Biotics LLC	People Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 Weeks
Secondary	To assess the effect of 2 different doses of the study product symptoms of sleep disturbance	Change in the Insomnia Sleep Index (ISI) score by 4.5 points between placebo and study product groups. Baseline period will be compared as well ISI scores between the 2 doses.	7 Weeks
Secondary	To assess the effect of 2 different doses of the study product on sleep quality	Change in average sleep quality score by 1 point as measured by daily 10-point visual analogue rating scale (VAS) between placebo and study product groups. Baseline period will be compared as well as average scores between the 2 doses.	7 Weeks
Secondary	To assess the effect of 2 different doses of the study product on quality of life	Change in average mood score by 1 point between placebo and study product groups as measured by a daily 10-point VAS scale. Baseline period will be compared as well the scores between the 2 doses.	7 Weeks
Secondary	To assess the effect of 2 different doses of the study product on cognitive ability	Change in average score between placebo and study product groups on the Cognitive Assessment: Raven's Progressive Matrices collected weekly. Baseline period will be compared as well the scores between the 2 doses.	7 Weeks