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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Placebo Comparator | GI Health Product Form - Control |
|
| Active product | Experimental | GI Health Product Form - Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Health Placebo Control | Dietary Supplement | Participants will use their GI Health Placebo Control as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in GI-related QoL (DQLQ) | Difference between rates of change over time in DQLQ score as assessed by Digestion-associated QoL (scale 0-9; where the higher scores correspond to worse GI-related quality of life) | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 3-60; where the higher scores correspond to worse gas and bloating) | 7 weeks |
| Change in Constipation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 7 weeks |
| Minimal clinical importance difference (MCID) in GI-Related Quality of Life (DQLQ) |
Inclusion Criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
o 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
Exclusion Criteria:
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.
o 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.
o 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
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| Name | Affiliation | Role |
|---|---|---|
| Susan Hewlings | Radicle Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014-2605 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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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.
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The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
| GI Health Active Product | Dietary Supplement | Participants will use their GI Health Active Product as directed for a period of 6 weeks. |
|
Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
| 7 weeks |
| Change in Diarrhea | Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea) | 7 weeks |
Likelihood of achieving a MCID in digestion-related quality of life, as measured by Digestion-associated QoL (scale 0-9; where the higher scores correspond to worse digestion-related quality of life) |
| 7 weeks |
| Minimal clinical importance difference (MCID) in Gas and Bloating | Likelihood of achieving a MCID in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-60; where the higher scores correspond to worse gas and bloating) | 7 weeks |
| Minimal clinical importance difference (MCID) in Constipation | Likelihood of achieving a MCID in constipation, as measured by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation) | 7 weeks |
| Minimal clinical importance difference (MCID) in Diarrhea 6A | Likelihood of achieving a MCID in diarrhea, as measured by PROMIS Diarrhea 6A scale (2-30; where the higher scores correspond to worse diarrhea) | 7 weeks |