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Probiotics for Anxiety Study
Sponsor: Verb Biotics LLC
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
122
Start Date
2024-03-04
Completion Date
2025-02-11
Last Updated
2024-11-14
Healthy Volunteers
Yes
Conditions
Interventions
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 (1)
People Science, Inc.
Los Angeles, California, United States