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

Probiotics for Anxiety Study (NCT06466603)

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

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: Review the eligibility criteria below.

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

Age range: 18 Years

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

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.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—