Health Products for Gastrointestinal Health

Overseen By Susan Hewlings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Major illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain health products can improve gastrointestinal (GI) health and related outcomes. Participants will receive either an active product (GI Health Product Form - Active) or a placebo (a substance with no active ingredient) to compare effects. The trial seeks adults in the U.S. willing to try these products without knowing which one they receive. Ideal participants should anticipate at least a 30% improvement in their GI health. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research in GI health.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they have a known interaction with the study products, such as blood thinners, blood pressure meds, or antidepressants. The trial does not specify a washout period, but it's important to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the GI Health Product, particularly the Radicle GI Health Active Study Product 1.1, aims to improve gut health through a blend of health-focused foods. Studies on similar products have found that people usually tolerate them well.

For example, past studies used a similar method, being randomized and placebo-controlled, to test safety and effectiveness. These studies did not find any major side effects, suggesting that the product is safe for most people. However, individual reactions can differ. Always consult a healthcare provider if there are concerns about trying new health products. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gastrointestinal health, which often include antacids, proton pump inhibitors, and dietary changes, the GI Health Product Form - Active offers a novel approach by using a unique combination of natural ingredients designed to enhance gut balance. Researchers are excited about this treatment because it targets the gut microbiome directly, potentially offering a more holistic and sustainable improvement in digestive health. Additionally, its natural formulation might reduce the risk of side effects commonly associated with conventional medications, making it an appealing option for long-term use.

What evidence suggests that this trial's treatments could be effective for gastrointestinal health?

This trial will compare the GI Health Product Form - Active with a placebo control. Research has shown that the GI Health Product may improve digestive health. Studies on similar products, such as Actbiome, have found significant benefits for gut health. These improvements can enhance overall well-being. Although data on this specific product remains limited, it appears to support digestion effectively. Overall, early findings suggest that these wellness products can positively impact digestive health. ^{1 2 5 6 7}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for individuals interested in improving their gastrointestinal (GI) health. Specific eligibility criteria are not provided, but typically participants should be healthy adults without any major GI issues that could interfere with the study.

Inclusion Criteria

I am 21 years old or older.

Has the opportunity for at least 30% improvement in their primary health outcome

Resides in the United States

Exclusion Criteria

Unable to provide a valid US shipping address and mobile phone number

Reports current enrollment in another clinical trial

Unable to read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 7 weeks, with self-reported data collected electronically

7 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GI Health Product Form - Active
• GI Product Form - Control

Trial Overview The study is testing a GI health product against a control form (placebo). It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product or placebo until after the results are analyzed.

How Is the Trial Designed?

Group I: Active Product Experimental Treatment 1 Intervention

GI Health Product Form - Active

Group II: Placebo Control Placebo Group 1 Intervention

GI Health Product Form - Control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06999642

Radicle GI Health™: A Study Assessing the Impact of ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.

2. withpower.com withpower.com/trial/phase-gastrointestinal-disorder-2-2024-5f8eb

Health Products for Gut Health · Info for Participants The research highlights the importance of assessing health-related quality of life (HRQoL) and patient-reported outcomes in gastrointestinal (GI) treatments.

3. clinicaltrial.be clinicaltrial.be/en/details/433711?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Radicle GI Health 24: A Study of Health and Wellness Prod... A randomized, double-blind, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on gastrointestinal (GI) health.

4. withpower.com withpower.com/trial/phase-gi-health-7-2025-3a575

Health Products for Gastrointestinal Health What is the purpose of this trial? A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212619821000206

Efficacy and safety of a gut health product (Actbiome) ... This study strongly suggested that the consumption of Actbiome would be a greater beneficial effect in the management of gut and gastrointestinal health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2857792/

A review of the gastrointestinal safety data— ... This article reviews the adverse effects of non-selective NSAID and cyclo-oxygenase-2 (COX-2) selective inhibitors in the upper and lower GI ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06376695/radicle-gi-health-24-a-study-of-health-and-wellness-products-on-gi-health-and-related-health-outcomes

Radicle GI Health 24: A Study of Health and Wellness ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.