An interventional study of Active Gut Feeling Product 1 and Active Gut Feeling Product 2 in Sleep Disturbance, Stress and Feeling Anxious, sponsored by Holobiome, Inc.. Recruiting at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Holobiome, Inc. · Not applicable, Interventional, and Other
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:
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 while maintaining scientific independence between the two waves. Each participant completes a 17-week study duration consisting of a 12-week double-blind intervention period (daily oral powder sachet consumed with food or beverage) followed by a 4-week washout period. This enables both within-arm time-course modeling and between-arm comparisons across intervention and post-intervention phases.
Following electronic informed consent, identity verification via one-time passcode, and baseline health assessments, participants are stratified to ensure balanced distribution across arms. Within each stratum, participants are randomized to active or shared placebo arms and to compensation tiers that will enable the assessment of how (if) compensation affects study participation and compliance.
To comprehensively track biological dynamics, the trial integrates multi-omic biospecimen collections and digital biomarker telemetry. Participants self-collect stool samples across four timepoints for deep metagenomic sequencing, untargeted fecal metabolomics, and to create a biobank. Finger-prick capillary blood samples are collected via microsampling devices for blood proteomic profiling at two time points. A consented sub-cohort applies an over-the-counter continuous glucose monitor for two weeks to evaluate glucose dynamics. Additional digital health streams include passive nightly wearable telemetry, weekly smartphone-based optical AI facial scans (Intelliprove) tracking physiological vitals, passive GPS-derived home-time proportion metrics, and weekly photographic food recall diaries.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Holobiome, Inc. as lead sponsor.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Criteria: 3.1 Inclusion
Participants must meet all of the following criteria:
3.2 Exclusion
Individuals who report any of the following during screening may be excluded from participation:
Note on medication exclusions: routine prescription medications (including antihypertensives, anticoagulants at standard outpatient doses, antiseizure medications, and medications carrying a grapefruit-consumption warning) are not categorically excluded. Specific medications posing a documented safety risk in combination with the food ingredients (products) are addressed by the study screening Q-bank.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Gut Feeling Product 1
Other: Active Gut Feeling Product 1
Active Gut Feeling Product 2
Other: Active Gut Feeling Product 2
Placebo Gut Feeling Product Control
Other: Placebo Gut Feeling Control Product
Participants will use their Active Gut Feeling Product 1 as directed for a period of 12 weeks
Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks
Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks
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
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
Change in measure of self-perceived success
Change in measure of self-perceived success: Difference between rates of change over time in measure of self-perceived success as assessed by Flourishing Scale (scale 1-7; with higher scores corresponding to stronger sense of psychological prosperity and functioning)
Time frame: 18 weeks
Change in depression, anxiety, and stress
Change in Depression, Anxiety, and Stress: Difference between rates of change over time in depression, anxiety, and stress as assessed by DASS-8 (scale 1-4; with higher scores corresponding to Higher feelings of Depression, Anxiety, and Stress)
Time frame: 18 weeks
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
Minimal clinically important difference (MCID) in measure of self-perceived success
Minimal clinically important difference (MCID) in measure of self-perceived success: Likelihood of experiencing minimal clinically important difference in measure of self-perceived success as assessed by Flourishing Scale (scale 1-7; with higher scores corresponding to stronger sense of psychological prosperity and functioning)
Time frame: 18 weeks
Minimal clinically important difference (MCID) in Depression, Anxiety, and Stress
Minimal clinically important difference (MCID) in Depression, Anxiety, and Stress: Likelihood of experiencing minimal clinically important difference in depression, anxiety, and stress score as assessed by DASS-8 (scale 1-4; with higher scores corresponding to Higher feelings of Depression, Anxiety, and Stress)
Time frame: 18 weeks
Change in gut microbiota composition
Change in gut microbiota composition: Evaluation of shifts in gut microbial taxonomy, alpha diversity, and beta diversity derived from deep shotgun metagenomic sequencing of stool samples collected at Baseline, Week 6, Week 12, and Week 16.
Time frame: 18 weeks
Change in fecal metabolome profile
Change in fecal metabolome profile: Evaluation of relative abundance changes and fold-changes in microbial and host metabolite profiles derived from untargeted metabolomic analysis of stool samples collected at Baseline, Week 6, Week 12, and Week 16.
Time frame: 18 weeks
Change in glucose dynamics
Changes in glucose dynamics: Assessment of glycemic dynamics (mean glucose in mg/dL, time in range percentage, and glucose variability) measured over a 2-week period (Weeks 12-13) using the over-the-counter Dexcom Stelo Continuous Glucose Sensor.
Time frame: 3 weeks
Change in self-reported physical metrics
Change in self-reported physical metrics: Evaluation of change in body weight (measured in pounds) and waist circumference (measured in inches), alongside self-reported height (measured in feet and inches).
Time frame: 18 weeks
Change in anxiety sensitivity
Change in anxiety sensitivity: Difference between rates of change over time in anxiety sensitivity score as assessed by the Anxiety Sensitivity Index (ASI-3; 18 items, scale 0-72; with higher scores corresponding to greater anxiety sensitivity).
Time frame: 18 weeks
Change in pain intensity and interference
Change in pain intensity and interference: Difference between rates of change over time in pain score as assessed by the 3-item PEG scale (Pain average, Enjoyment of life interference, General activity interference; scale 0-10; with higher scores corresponding to greater pain intensity and interference).
Time frame: 18 weeks
Change in optical AI-facial scan vital signs and wellness metrics
Change in optical AI-facial scan vital signs and wellness metrics: Weekly evaluation of smartphone optical facial video scans (Intelliprove) tracking physiological vital signs (heart rate in bpm, HRV in ms, blood pressure in mmHg, respiratory rate in breaths/min) and AI-derived scores for mental wellness, stress, and sleep quality.
Time frame: 18 weeks
Change in wearable device continuous physiological telemetry
Change in wearable device continuous physiological telemetry: Continuous longitudinal tracking of physiological metrics collected via participants' existing wearable devices, including nightly sleep duration (hours/minutes), resting heart rate variability (HRV in ms), and daily physical activity (step counts, active minutes).
Time frame: 18 weeks
Change in GPS home-time proportion
Change in GPS-derived home-time proportion: Change in daily proportion of total time spent at home location (percentage range 0% to 100%) calculated via smartphone app geolocation tracking to establish behavioral and mobility patterns over time.
Time frame: 18 weeks
Correlation between digital biomarkers and patient-reported outcomes
Correlation between digital biomarkers and patient-reported outcomes: Evaluation of longitudinal statistical correlations between continuous digital health metrics (wearable telemetry, facial optical scan vitals, GPS home-time) and self-reported health outcome scores.
Time frame: 18 weeks
Impact of compensation on participant compliance
Impact of compensation on participant compliance: Evaluation of the effect (if any) of monetary compensation tier (A, B, or C) on participant compliance with biospecimen sample collection (1-4 timepoints of biospecimens returned).
Time frame: 18 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 102 industry-sponsored interventional studies with no phase under Anxiety Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 12 months is above that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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