Health and Wellness Products for Gut Health

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

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

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, 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 explores how health and wellness products might improve gut health and related outcomes. Participants will receive either an active product designed to support GI health (GI Health Active Product) or a placebo (a harmless pill with no active ingredients) to compare effects. The trial seeks U.S. residents who struggle with gut issues and believe they might experience at least a 30% improvement in symptoms. Participants must be willing to take the study product without knowing if it's the active one or the placebo until the study concludes.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research in gut health.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, chemotherapy, and others. If you're on any of these, you might need to stop them to participate.

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

Research shows that products designed for gut health, like the GI Health Active Product, are generally easy to use without problems. Studies on similar gut health products, such as Actbiome, have shown they can help with stomach issues and usually cause only minor side effects. Probiotics, often included in these products, are typically safe for most people. If side effects occur, they are usually mild, such as gas or bloating. Studies of similar products have reported no serious problems. This suggests that the GI Health Active Product is likely safe for use, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GI Health Active Product for gut health because it offers a novel approach compared to traditional treatments like probiotics and dietary changes. Unlike these standard options that mainly focus on replenishing beneficial bacteria or altering diet, this new product potentially introduces a unique active ingredient specifically designed to target gut health at a biochemical level. This innovation could lead to more effective and quicker relief for digestive issues by directly enhancing the gut's natural functions, setting it apart from existing methods.

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

Research has shown that the GI Health Active Product, which participants in this trial may receive, might significantly alleviate stomach and digestive issues. One study demonstrated that a similar herbal formula reduced the severity of these issues by 56% to 62% and decreased their frequency by 64%. Probiotics, commonly found in gut health products, have shown small positive effects on overall health, particularly by potentially lowering the risk of digestive problems. These findings suggest that the GI Health Active Product could effectively improve gut health by reducing the severity and frequency of symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 21 living in the US who have gastrointestinal issues with room for improvement. It's open to all ethnicities, races, and gender identities. Participants must be willing to take a product without knowing if it's active or placebo until the study ends.

Inclusion Criteria

I live in the United States.

I am at least 21 years old and consent to participate.

My participation will be based on my sex assigned at birth.

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 Active Product
• GI Health Placebo Control

Trial Overview The study is testing a GI health wellness product against a placebo (a harmless pill with no medical effect). Participants are randomly assigned to one of these two groups without knowing which one they're in, and both groups' GI health will be compared.

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. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3065426/

'Gut health': a new objective in medicine? - PMC Actually, gut health comprises a healthy upper and lower GI tract, although the term might suggest that it is restricted to the lower GI tract.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06564285

The Effects of a Novel Nutritional Product on Nutrient Gaps ... This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability. Official Title. The Effects of a Novel ...

4. gastrojournal.org gastrojournal.org/article/S0016-5085%2825%2900329-4/fulltext

Exercise, the Gut Microbiome and Gastrointestinal Diseases Probiotic supplementation could yield small beneficial effects in promoting health in trained individuals, likely by reducing the risk of respiratory and GI ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S027153171931187X

Herbal formula improves upper and lower gastrointestinal ... The NC Gut Relief Formula significantly improved the severity of the GI symptoms by 56%-62% and reduced their frequency by 64%, including indigestion, heartburn ...

6. 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.

7. fda.gov fda.gov/consumers/health-fraud-scams/health-fraud-product-database

Health Fraud Product Database This list includes unapproved products that have been subject to FDA health fraud related violations. These products have been cited in warning letters.

8. 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 ...

9. nccih.nih.gov nccih.nih.gov/health/probiotics-usefulness-and-safety

Probiotics: Usefulness and Safety | NCCIH - NIH Learn about probiotic dietary supplements and foods, including their uses for health purposes, scientific evidence regarding their use, and side effects and ...