Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

Launched by RADICLE SCIENCE · Apr 18, 2024

Keywords

ClinConnect Summary

The Radicle GI Health 24 study is looking at how certain health and wellness products can improve digestive health, particularly for people experiencing abdominal pain, bloating, or other gastrointestinal (GI) issues. This clinical trial is currently recruiting participants aged 21 and older from all backgrounds who want to enhance their bowel habits and reduce discomfort. To be eligible, you should be living in the United States and willing to try a product while keeping its identity a secret until the study is over.

If you join the study, you’ll either receive the active product or a placebo (a pill with no active ingredients) without knowing which one it is. This way, researchers can accurately measure the product's effects. However, some people won't be able to participate, such as those who are pregnant, have certain serious health conditions, or are involved in other clinical trials. If you’re interested in improving your GI health and meet the criteria, this could be a great opportunity to help researchers learn more about these wellness products.

Gender

ALL

Eligibility 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