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

ConditionsSleep Disturbance Stress Feeling Anxious

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

1,000 Participants

are divided into 3 treatment groups

Group A: Active Gut Feeling Product 1Experimental treatment 1 intervention

Group B: Active Gut Feeling Product 2Experimental treatment 1 intervention

Group C: Placebo Gut Feeling Product ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

18 weeks

Secondary outcomes

Change in sleep

Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Time frame

18 weeks

Change in severity of generalized anxiety

Change in severity of generalized anxiety: Difference between rates of change over time in feelings of generalized anxiety score as assessed by GAD-7 (scale 0-21; with higher scores corresponding to more severe anxiety)

Time frame

18 weeks

Change in the severity of depression

Change in the severity of depression: Difference between rates of change over time in severity of depression as assessed by PHQ-9 (scale 0-27; with higher scores corresponding to more severe depression)

Time frame

18 weeks

Change in recovery from stress and adversity

Change in recovery from stress and adversity: Difference between rates of change over time in recovery from stress and adversity as assessed by Brief Resilience Scale (scale 1-5; with higher scores corresponding to Higher Recovery)

Time frame

18 weeks

Other outcomes

Minimal clinically important difference (MCID) in feelings of anxiety

Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety) or assessed by GAD-7 (scale 0-21; with higher scores corresponding to more severe anxiety).

Time frame

18 weeks

Minimal clinically important difference (MCID) in sleep

Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Time frame

18 weeks

Minimal clinically important difference (MCID) in severity of depression

Minimal clinically important difference (MCID) in severity of depression: Likelihood of experiencing minimal clinically important difference in depression score as assessed by PHQ-9 (scale 0-27; with higher scores corresponding to more severe depression)

Time frame

18 weeks

Minimal clinically important difference (MCID) in recovery from stress and adversity

Minimal clinically important difference (MCID) in recovery from stress and adversity: Likelihood of experiencing minimal clinically important difference in recovery from stress and adversity score as assessed by Brief Resilience Scale (scale 1-5; with higher scores corresponding to Higher Recovery)

Time frame

18 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holobiome, Inc.

Lead sponsor

Radicle Science

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: