GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults

Part of paid clinical trials in Del Mar, California.

Sponsor
Holobiome, Inc.
Study ID
NCT07752823
Status
Not Yet Recruiting

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Conditions

  • Feeling Anxious
  • Sleep Disturbance
  • Stress

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Active Gut Feeling Product 1 — OTHER
    Participants will use their Active Gut Feeling Product 1 as directed for a period of 12 weeks
  • Active Gut Feeling Product 2 — OTHER
    Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks
  • Placebo Gut Feeling Control Product — OTHER
    Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks

Study Details

The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is: \- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo? Researchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety. Participants will: * Be randomly assigned to receive either an active product or a placebo (an inactive look-alike). * Take their assigned product or placebo without knowing which group they are in until the study is completed. * Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Active Gut Feeling Product 1
    Active Gut Feeling Product 1
  • Experimental: Active Gut Feeling Product 2
    Active Gut Feeling Product 2
  • Placebo Comparator: Placebo Gut Feeling Product Control
    Placebo Gut Feeling Product Control

Primary Outcome Measure

Change in feelings of anxiety [ Time Frame: 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Radicle Science Inc.Del MarCalifornia92014-2605
Study Manager
[email protected]
760-281-3898
Megan Moseley
[email protected]

Find similar trials in Del Mar, CA

By research site
Radicle Science Inc.· Del Mar, CA

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