GI HealthNCT07212231
Radicle GI Health: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes.
A study testing Active Product 1, Active Product 2 and Active Product 3 in people with GI Health, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI Health and related health outcomes. Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- GI Health
- What is being tested?
- Active Product 1, Active Product 2 and Active Product 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,501 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants must meet all the following criteria:
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities.
- Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed.
- Resides in the United States.
- Has the opportunity for at least 30% improvement in their primary health outcome.
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study.
Individuals who report any of the following during screening will be excluded from participation:
- Report being pregnant, trying to become pregnant, or breastfeeding.
- Unable to provide a valid US shipping address and mobile phone number.
- Reports current enrollment in another clinical trial.
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).
- Unable to read and understand English.
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure.
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products.
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk.
- Lack of reliable daily access to the internet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle GI HealthTM RVS: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes.
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI Health and related health outcomes.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- GI Health
- Being tested
- GI Product Placebo Control, Active Product 1, Active Product 2, Active Product 3, Active Product 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Product Placebo ControlDietary supplement
Participants will use their GI Product Placebo Control as directed for a period of 6 weeks.
Active Product 1Dietary supplement
Participants will use their GI Active Product 1 as directed for a period of 6 weeks.
Active Product 2Dietary supplement
Participants will use their GI Active Product 2 as directed for a period of 6 weeks.
Active Product 3Dietary supplement
Participants will use their GI Active Product 3 as directed for a period of 6 weeks.
Active Product 4Dietary supplement
Participants will use their GI Active Product 4 as directed for a period of 6 weeks.
Active Product 5Dietary supplement
Participants will use their GI Active Product 5 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | GI Product Placebo Control Receives: Dietary Supplement: GI Product Placebo Control |
| Active Product 1 | Experimental | GI Active Product 1 Receives: Dietary Supplement: Active Product 1 |
| Active Product 2 | Experimental | GI Active Product 2 Receives: Dietary Supplement: Active Product 2 |
| Active Product 3 | Experimental | GI Active Product 3 Receives: Dietary Supplement: Active Product 3 |
| Active Product 4 | Experimental | GI Active Product 4 Receives: Dietary Supplement: Active Product 4 |
| Active Product 5 | Experimental | GI Active Product 5 Receives: Dietary Supplement: Active Product 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower GI health
Difference between rates of change over time in lower GI collective score as assessed by a composite of PROMIS Gas and Bloating 13A , Constipation 9A, Diarrhea 6A, and Belly Pain 5A (scores 10-84; where the higher scores correspond to worse lower GI health)
Measured: 7 weeks
Secondary outcomes (3)
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
Measured: 7 weeks
Change in GI-related quality of life
Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Measured: 7 weeks
Change in global health
Change in global health: Difference in rates of change over time in global score as assessed by PROMIS Global health (scale 9-45; where higher scores correspond to better global health).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start16 Oct 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI HealthStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212231
- Sponsor's protocol ID
- RADX_P_2407_RVS
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle GI HealthTM RVS: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes.
- ClinicalTrials.gov ID
- NCT07212231
- Acronym / sponsor ID
- RADX_P_2407_RVS
- Conditions
- GI Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI Health and related health outcomes.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: GI Product Placebo ControlGI Product Placebo Control |
| Active Product 1 | Experimental | Dietary Supplement: Active Product 1GI Active Product 1 |
| Active Product 2 | Experimental | Dietary Supplement: Active Product 2GI Active Product 2 |
| Active Product 3 | Experimental | Dietary Supplement: Active Product 3GI Active Product 3 |
| Active Product 4 | Experimental | Dietary Supplement: Active Product 4GI Active Product 4 |
| Active Product 5 | Experimental | Dietary Supplement: Active Product 5GI Active Product 5 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI Product Placebo ControlParticipants will use their GI Product Placebo Control as directed for a period of 6 weeks. | Dietary supplement | Placebo Control |
| Active Product 1Participants will use their GI Active Product 1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1 |
| Active Product 2Participants will use their GI Active Product 2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2 |
| Active Product 3Participants will use their GI Active Product 3 as directed for a period of 6 weeks. | Dietary supplement | Active Product 3 |
| Active Product 4Participants will use their GI Active Product 4 as directed for a period of 6 weeks. | Dietary supplement | Active Product 4 |
| Active Product 5Participants will use their GI Active Product 5 as directed for a period of 6 weeks. | Dietary supplement | Active Product 5 |
Primary outcome
Change in lower GI health
Time frame: 7 weeks
Difference between rates of change over time in lower GI collective score as assessed by a composite of PROMIS Gas and Bloating 13A , Constipation 9A, Diarrhea 6A, and Belly Pain 5A (scores 10-84; where the higher scores correspond to worse lower GI health)
3 secondary outcomes
Change in sleep
Time frame: 7 weeks
Change in GI-related quality of life
Time frame: 7 weeks
Change in global health
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Product 1, Active Product 2 and Active Product 3 in people with GI Health, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower GI health (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.