GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorHolobiome, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 21-80 years (inclusive) at the time of electronic informed consent, of any ethnicity, race, or gender identity
Assigned sex at birth determines sex-specific PRO branching (e.g., menstrual interference) where applicable
Reside in the contiguous 48 states in the United States and is able to provide a valid US shipping address and and 10-digit mobile phone number
Per state regulations, individuals residing in New York, New Jersey, and Rhode Island will be excluded
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Active Gut Feeling Product 1
- Active Gut Feeling Product 2
- Placebo Gut Feeling Control Product
Treatment groups
1,000 Participants
are divided into 3 treatment groupsSponsors and collaborators
Holobiome, Inc.
Lead sponsor
Radicle Science
Collaborator
Source ClinicalTrials.gov