Health and wellness products for belly pain and overall GI health
Radicle GI Health DBG™: A Randomized, Double-Blind, Placebo Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
This randomized, double-blind test will see if two health-and-wellness products compared with a placebo can reduce belly pain and improve GI symptoms in adults living in the United States.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 825 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT07318077 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial enrolls adults aged 21 and older in the United States to compare two active GI health products with a matched placebo. Participants are randomized and neither participants nor study staff know product identity during the six-week active period. All outcome data are self-reported electronically with no in-person visits; products are shipped and assessments are completed via mobile or online surveys. People with significant cardiac, liver, or kidney disease, heavy alcohol use, pregnancy or breastfeeding, or taking contraindicated medications are excluded.
Who should consider this trial
Good fit: Adults (21+) in the U.S. with belly pain or other GI symptoms who are willing to take a blinded product, can complete electronic reporting and shipping requirements, and do not have serious cardiac, liver, or kidney disease or other exclusionary conditions.
Not a fit: People who are pregnant, trying to become pregnant, breastfeeding, heavy drinkers, have serious cardiac/liver/kidney disease, or require contraindicated medications are likely excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these products could reduce belly pain and improve overall GI symptoms for people with GI complaints.
How similar studies have performed: Randomized, placebo-controlled trials of GI wellness supplements have shown mixed results, with some agents producing modest symptom improvements while many products remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion 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 * Unable to verify their identity during consent using Veriff * 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 at approx. 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. * 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
Where this trial is running
Del Mar, California
- Radicle Science Inc. — Del Mar, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan Hewlings — Radicle Science
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 858-779-0086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.