GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults, Wave 1
Holobiome, Inc.
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.
Description
This is a parallel group, randomized, double-blind, placebo-controlled study assessing the effects (if any) of different prebiotics (products) on self-reported feelings of anxiety and related health outcomes. The study is conducted in two sequential waves, each enrolling a similar population and evaluating distinct interventions, under a unified master protocol. Participants will not know their study arm assignment until the study is completed. The master protocol structure permits an efficient shared infrastructure for oversight, data management, safety monitoring, and biospecimen handling w…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- Yes
Criteria: 3.1 Inclusion Participants must meet all of the following criteria: * 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 * Capable of providing voluntary,…
Interventions
- OtherActive Gut Feeling Product 1
Participants will use their Active Gut Feeling Product 1 as directed for a period of 12 weeks
- OtherActive Gut Feeling Product 2
Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks
- OtherPlacebo Gut Feeling Control Product
Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks
Location
- Radicle Science Inc.Del Mar, California