๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-11-12

Probiotics for Anxiety Study (NCT06466603)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Verb Biotics LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (10 items).

Location: People Science, Inc. โ€” Los Angeles, California

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • People Science, Inc. โ€” Los Angeles, California

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—