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

NCT07752823 | Not Yet Recruiting

• 1 other identifier: RADX_P_2610_DHB_W1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disturbance; Stress; Feeling Anxious

Outcome Measures

Primary Outcomes (1)

• Change in feelings of anxiety

  Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)

  18 weeks

Secondary Outcomes (6)

• Change in sleep

  18 weeks

• Change in severity of generalized anxiety

  18 weeks

• Change in the severity of depression

  18 weeks

• Change in recovery from stress and adversity

  18 weeks

• Change in measure of self-perceived success

  18 weeks

Other Outcomes (17)

• Minimal clinically important difference (MCID) in feelings of anxiety

  18 weeks

• Minimal clinically important difference (MCID) in sleep

  18 weeks

• Minimal clinically important difference (MCID) in severity of depression

  18 weeks

Study Arms (3)

Active Gut Feeling Product 1

EXPERIMENTAL

Active Gut Feeling Product 1

Other: Active Gut Feeling Product 1

Active Gut Feeling Product 2

EXPERIMENTAL

Active Gut Feeling Product 2

Other: Active Gut Feeling Product 2

Placebo Gut Feeling Product Control

PLACEBO COMPARATOR

Placebo Gut Feeling Product Control

Other: Placebo Gut Feeling Control Product

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 1

Active Gut Feeling Product 2 OTHER

Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks

Active Gut Feeling Product 2

Placebo Gut Feeling Control Product OTHER

Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks

Placebo Gut Feeling Product Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants residing in the states of New York, New Jersey, or Rhode Island are not eligible to participate in the study. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the study. No alternative collection pathway is available under the current protocol.
• To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be eligible. This automated screening ensures that ineligible participants are not inadvertently enrolled in the study.

Sponsors & Collaborators

• Holobiome, Inc.: lead
• Radicle Science: collaborator

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who complete enrollment will first be stratified to ensure balanced distribution across study arms. Stratification is based on sex at birth (female, non-female), age (21-39, 40-59, ≥60 years), wearable sub-study enrollment (yes/no), continuous glucose monitor (CGM) interest (yes/no), and PROMIS™ Anxiety 8A T-score category (mild: 55.0-59.9, moderate-low: 60.0-64.9, moderate-high: 65.0-69.9). Study product formulation is not included as a stratification factor. Within each stratum, participants are sequentially randomized to either an active study product arm or the shared placebo arm. Randomization uses equal probability of assignment to any active arm while maintaining the prespecified placebo-to-active allocation ratios based on Dunnett's optimal allocation for the number of active treatment arms.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)