Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06466603
Eligibility Criteria:
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 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06466603
Study Brief:
Protocol Section:
NCT06466603