DigestionNCT06009614
Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes
A study testing Radicle GI Health Active Study Product 1.1 Usage, Radicle GI Health Active Study Product 2.1 Usage and Radicle GI Health Active Study Product 2.2 Usage in people with Digestion and Abdominal Pain, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other 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
- Digestion, Abdominal Pain, GI Disorders
- What is being tested?
- Radicle GI Health Active Study Product 1.1 Usage, Radicle GI Health Active Study Product 2.1 Usage and Radicle GI Health Active Study Product 2.2 Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 20 Feb 2024
- 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
Who may be able to join
- Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Resides in the United States
- Endorses less bloating or indigestion as a primary desire
- Has the opportunity for at least 20% improvement in their primary health outcome score
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Who cannot join
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- The calculated validated health survey (PRO) score during enrollment represents less than mild severity
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
Show all 11Show fewer
- Reports current enrollment in another clinical trial
- Lack of reliable daily access to the internet
- Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
- Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
- Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
Read the detailed description
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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
- Digestion, Abdominal Pain, GI Disorders
- Being tested
- Radicle GI Health Placebo Control Form 1, Radicle GI Health Active Study Product 1.1 Usage, Radicle GI Health Placebo Control Form 2, Radicle GI Health Active Study Product 2.1 Usage, Radicle GI Health Active Study Product 2.2 Usage
- Medical subject headings
- Abdominal Pain, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radicle GI Health Placebo Control Form 1Dietary supplement
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 1.1 UsageDietary supplement
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Radicle GI Health Placebo Control Form 2Dietary supplement
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 2.1 UsageDietary supplement
Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 2.2 UsageDietary supplement
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Radicle GI Health Placebo Control Form 3Dietary supplement
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 3.1 UsageDietary supplement
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | GI Health Product Form 1 - control Receives: Dietary Supplement: Radicle GI Health Placebo Control Form 1 |
| Active Product 1.1 | Experimental | GI Health Product Form 1 - active product 1 Receives: Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage |
| Placebo Control 2 | Placebo comparator | GI Health Product Form 2 - control Receives: Dietary Supplement: Radicle GI Health Placebo Control Form 2 |
| Active Product 2.1 | Experimental | GI Health Product Form 2 - active product 1 Receives: Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage |
| Active Product 2.2 | Experimental | GI Health Product Form 2 - active product 2 Receives: Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage |
| Placebo Control 3 | Placebo comparator | GI Health Product Form 3 - control Receives: Dietary Supplement: Radicle GI Health Placebo Control Form 3 |
| Active Product 3.1 | Experimental | GI Health Product Form 3 - active product 1 Receives: Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
Measured: 6 weeks
Secondary outcomes (6)
Change in abdominal pain
Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
Measured: 6 weeks
Change in gas/bloating
Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
Measured: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Minimal clinically important difference (MCID) in GI-related QOL
Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
Measured: 6 weeks
Minimal clinically important difference (MCID) in abdominal pain
Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Measured: 6 weeks
Minimal clinically important difference (MCID) in gas/bloating
Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Aug 2023
- Primary completion30 Nov 2023
- Study completion20 Feb 2024
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
- Participants will be stratified based on gender at birth then randomized to one of the study arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K. Pauli, PharmD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009614
- Sponsor's protocol ID
- RADX-2307
- Status last verified
- May 2024
- First submitted
- 18 Aug 2023
- Last updated
- 20 May 2024
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes
- ClinicalTrials.gov ID
- NCT06009614
- Acronym / sponsor ID
- RADX-2307
- Conditions
- Digestion, Abdominal Pain, GI Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,180 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Aug 2023 (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, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
Detailed description
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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
- 7
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Radicle GI Health Placebo Control Form 1GI Health Product Form 1 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Radicle GI Health Active Study Product 1.1 UsageGI Health Product Form 1 - active product 1 |
| Placebo Control 2 | Placebo comparator | Dietary Supplement: Radicle GI Health Placebo Control Form 2GI Health Product Form 2 - control |
| Active Product 2.1 | Experimental | Dietary Supplement: Radicle GI Health Active Study Product 2.1 UsageGI Health Product Form 2 - active product 1 |
| Active Product 2.2 | Experimental | Dietary Supplement: Radicle GI Health Active Study Product 2.2 UsageGI Health Product Form 2 - active product 2 |
| Placebo Control 3 | Placebo comparator | Dietary Supplement: Radicle GI Health Placebo Control Form 3GI Health Product Form 3 - control |
| Active Product 3.1 | Experimental | Dietary Supplement: Radicle GI Health Active Study Product 3.1 UsageGI Health Product Form 3 - active product 1 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Resides in the United States
- Endorses less bloating or indigestion as a primary desire
- Has the opportunity for at least 20% improvement in their primary health outcome score
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Key exclusion criteria (11 listed)
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- The calculated validated health survey (PRO) score during enrollment represents less than mild severity
- Reports a diagnosis of liver or kidney disease
- 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 |
|---|---|---|
| Radicle GI Health Placebo Control Form 1Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 1 |
| Radicle GI Health Active Study Product 1.1 UsageParticipants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.1 |
| Radicle GI Health Placebo Control Form 2Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 2 |
| Radicle GI Health Active Study Product 2.1 UsageParticipants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2.1 |
| Radicle GI Health Active Study Product 2.2 UsageParticipants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 2.2 |
| Radicle GI Health Placebo Control Form 3Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 3 |
| Radicle GI Health Active Study Product 3.1 UsageParticipants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 3.1 |
Primary outcome
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
Time frame: 6 weeks
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
6 secondary outcomes
Change in abdominal pain
Time frame: 6 weeks
Change in gas/bloating
Time frame: 6 weeks
Change in feelings of anxiety
Time frame: 6 weeks
Minimal clinically important difference (MCID) in GI-related QOL
Time frame: 6 weeks
Minimal clinically important difference (MCID) in abdominal pain
Time frame: 6 weeks
Minimal clinically important difference (MCID) in gas/bloating
Time frame: 6 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 20 May 2024.
- Radicle Science, IncLink 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.
Emily K. Pauli, PharmD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radicle GI Health Active Study Product 1.1 Usage, Radicle GI Health Active Study Product 2.1 Usage and Radicle GI Health Active Study Product 2.2 Usage in people with Digestion and Abdominal Pain, 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 20 May 2024. 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 GI (Gastrointestinal) - related Quality of Life (QOL) (time frame: 6 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 20 May 2024.