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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT06466603
• Study type: Observational
• Source: Verb Biotics LLC
• Status: Active, not recruiting
• Start date: March 4, 2024
• Completion date: February 11, 2025