DigestionNCT07873216
Radicle GI HealthTM VKP: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-related Quality of Life and Related Health Outcomes
A study testing Active GI Health Product in people with Digestion and GI Health, run by Radicle Science at 1 site in United States.
Trial summary
Radicle GI Health VKP: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal-related quality of life and related health outcomes. Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- What is being tested?
- Active GI Health Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 29 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
None listed.
Who cannot join
- Individuals who report any of the following during screening may be excluded from participation.
- See the screening survey in the appendices for items marked for ineligibility:
- 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)
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- Unable to read and understand English at a 7th grade level
- 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. This may include:
- 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. This may include:
- 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 pre/probiotic usage within the last month
- Reports prior GI surgery, IBD diagnosis, or Celiac disease diagnosis
- 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
- Reports initiating or changing GLP-1 dose within the past 3 months
- Reports chronic opioid use
- Reports initiation or changing proton pump inhibitors within the past 3 months
- Reports using laxatives/anti-diarrheal medications once per week or more in the past 3 months
- Lack of reliable daily access to the internet
- Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. 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 biomarker collection. 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 presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Radicle Science, Inc
Del Mar, California, 92014
Study Manager, 760-281-3898, studymgmt@radiclescience.com
Megan Moseley, megan@radiclescience.com
About this study
Official title: Radicle GI HealthTM VKP: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-related Quality of Life and Related Health Outcomes
Radicle GI Health VKP: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal-related quality of life 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 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 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Being tested
- Placebo GI Health Control, Active GI Health Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GI Health ControlDietary supplement
Participants will use their Placebo GI Health Control as directed for a period of 8 weeks
Active GI Health ProductDietary supplement
Participants will use their Active GI Health Product as directed for a period of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active GI Health Product 1 | Active comparator | Active GI Health Product 1 Receives: Dietary Supplement: Active GI Health Product |
| Placebo GI Health Control | Placebo comparator | Placebo GI Health Control Receives: Dietary Supplement: Placebo GI Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GI-related Quality of Life (QOL)
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: 9 weeks
Secondary outcomes (3)
Change in Belly Pain
Change in Belly Pain: Difference between rates of change over time in belly pain score as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain)
Measured: 9 weeks
Change in Gas and Bloating
Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
Measured: 9 weeks
Bristol Stool Form Scale (BSFS)
The Bristol Stool Form Scale (BSFS) is a 7-point scale used to classify stool consistency and form. Stool types range from Type 1 (separate hard lumps) to Type 7 (watery, entirely liquid stool). Lower scores indicate harder stool consistency, while higher scores indicate looser stool consistency. Types 3 and 4 are generally considered indicative of normal stool form. Scores range from 1 to 7.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start29 Oct 2026 (estimated)
- Primary completion29 Oct 2027 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DigestionStudies 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
- Eligible participants must complete all enrollment requirements prior to stratification and randomization. Participants will be stratified based on sex at birth (Female or Non-Female), GLP-1 use (Yes or No), and health outcome score according to the applicable published scoring guidelines and defined categories or thresholds. Participants will then be sequentially randomized to one of the study groups using all stratification factors collectively to support balanced distribution across study product groups. Following randomization, participants will receive their assigned study product along with an insert containing instructions for product use and additional information regarding study procedures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valerie Starratt, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873216
- Sponsor's protocol ID
- RADX_P_2607_VKP
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle GI HealthTM VKP: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-related Quality of Life and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07873216
- Acronym / sponsor ID
- RADX_P_2607_VKP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
Radicle GI Health VKP: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal-related quality of life 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 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 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. 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
- 2
- Model description
- Eligible participants must complete all enrollment requirements prior to stratification and randomization. Participants will be stratified based on sex at birth (Female or Non-Female), GLP-1 use (Yes or No), and health outcome score according to the applicable published scoring guidelines and defined categories or thresholds. Participants will then be sequentially randomized to one of the study groups using all stratification factors collectively to support balanced distribution across study product groups. Following randomization, participants will receive their assigned study product along with an insert containing instructions for product use and additional information regarding study procedures.
| Arm | Type | Receives |
|---|---|---|
| Active GI Health Product 1 | Active comparator | Dietary Supplement: Active GI Health ProductActive GI Health Product 1 |
| Placebo GI Health Control | Placebo comparator | Dietary Supplement: Placebo GI Health ControlPlacebo GI Health Control |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- Individuals who report any of the following during screening may 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)
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 |
|---|---|---|
| Placebo GI Health ControlParticipants will use their Placebo GI Health Control as directed for a period of 8 weeks | Dietary supplement | Placebo GI Health Control |
| Active GI Health ProductParticipants will use their Active GI Health Product as directed for a period of 8 weeks | Dietary supplement | Active GI Health Product 1 |
Primary outcome
Change in GI-related Quality of Life (QOL)
Time frame: 9 weeks
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)
3 secondary outcomes
Change in Belly Pain
Time frame: 9 weeks
Change in Gas and Bloating
Time frame: 9 weeks
Bristol Stool Form Scale (BSFS)
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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.
Valerie Starratt 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 GI Health Product in people with Digestion and 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?
The sponsor lists 0 inclusion and 22 exclusion criteria. 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: opening soon, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (858-779-0086, studymgmt@radiclescience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GI-related Quality of Life (QOL) (time frame: 9 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 14 Oct 2026.