Probiotics for Anxiety Study (NCT06466603) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Probiotics for Anxiety Study
United States122 participantsStarted 2024-03-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Illnes…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To observe the effect of the 2 different doses of the study product on anxiety