Health and Wellness Products for Gut Health

SM
Overseen ByStudy Manager

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.12345

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.26789

Who Is on the Research Team?

SH

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active productExperimental Treatment1 Intervention
Group II: Placebo controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials
24
Recruited
46,200+

Citations

Health Products for Gut Health · Info for ParticipantsThe research highlights the importance of assessing health-related quality of life (HRQoL) and patient-reported outcomes in gastrointestinal (GI) treatments.
'Gut health': a new objective in medicine? - PMCActually, gut health comprises a healthy upper and lower GI tract, although the term might suggest that it is restricted to the lower GI tract.
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 ...
Exercise, the Gut Microbiome and Gastrointestinal DiseasesProbiotic supplementation could yield small beneficial effects in promoting health in trained individuals, likely by reducing the risk of respiratory and GI ...
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 ...
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.
Health Fraud Product DatabaseThis list includes unapproved products that have been subject to FDA health fraud related violations. These products have been cited in warning letters.
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 ...
Probiotics: Usefulness and Safety | NCCIH - NIHLearn about probiotic dietary supplements and foods, including their uses for health purposes, scientific evidence regarding their use, and side effects and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security