Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Probiotics for Anxiety Study
Sponsor:
Verb Biotics LLC
Organization:
Verb Biotics LLC
Study Overview
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 productplacebo 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None