Assessing health and wellness products for gastrointestinal health
Radicle GI Health™ 24: 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
This study is testing whether certain health products can help adults feel better by improving their stomach issues like bloating and indigestion over seven weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2100 (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 | NCT06376695 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, double-blind, placebo-controlled trial that evaluates the effects of health and wellness products on gastrointestinal health and related outcomes in adults. Participants will report their bowel habits, bloating, indigestion, and stomach pain over a 7-week period using electronic surveys. The study aims to determine if these products can lead to a meaningful improvement in gastrointestinal symptoms. All assessments will be conducted electronically, with no in-person visits required.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older residing in the United States who seek to improve their bowel habits and gastrointestinal symptoms.
Not a fit: Patients with known cardiac dysfunction, liver or kidney disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective health and wellness products to improve gastrointestinal health.
How similar studies have performed: Other studies have shown success with similar approaches in assessing health products for gastrointestinal health, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 * Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains * Has the opportunity for at least 20% 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. NYHA (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), 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 product * 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: Emily K. Pauli, PharmD — Radicle Science, Inc
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
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.