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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To observe the effect of the 2 different doses of the study product on anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To observe the effect of the 2 different doses of the study product on anxiety
时间窗: 7 Weeks
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.
次要结局
- 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)