1650 Participants Needed

Health Products for Gut Health

SH
SM
Overseen ByStudy Manager

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different health products affect gut health and related outcomes. Participants will be randomly assigned to one of five products (Active Product 1, Active Product 2, Active Product 3, Active Product 4, or Active Product 5) or a placebo. Neither participants nor researchers will know who receives which product until the trial concludes. It is ideal for U.S. residents who anticipate at least a 30% improvement in gut health by trying something new and are comfortable not knowing if they are taking an active product or a placebo. As an unphased trial, this study offers a unique opportunity to explore innovative health solutions and contribute to advancing gut health research.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study products. These include blood thinners, blood pressure meds, anxiety or depression meds, and others. It's best to discuss your specific medications with the study team.

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

Research has shown that probiotics, commonly found in gut health products, have been used safely for many years. However, safety results can vary and are not always reported consistently in studies. This means that while these products are generally well-tolerated, specific details might not always be available.

For Active Product 1, studies suggest that similar gut health products help manage gut health without major safety issues, though specific side effects are not always clear.

Active Product 2 might also include probiotics, and their safety usually depends on factors like the amount used and the duration of use. Long-term use can sometimes cause increased inflammation, though this is rare.

Active Product 3 and Active Product 4, which also seem to include probiotics, have been shown to support digestive health. However, severe infections have been noted in rare cases, especially in vulnerable groups like premature infants.

Active Product 5 is another probiotic product known for supporting the gut microbiome, which is the community of microorganisms in the digestive system. Like the others, it is generally safe but may have rare side effects.

Overall, while these products are often safe, individual experiences may vary. Always consider consulting a healthcare provider before starting any new treatment.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for gut health because they offer new ways to balance the gastrointestinal environment. Unlike current probiotics or dietary supplements that mostly focus on general gut flora improvement, these active products are designed to target specific aspects of gut health. Each product might work by introducing unique beneficial bacteria strains or delivering compounds that enhance gut barrier function. This targeted approach could potentially lead to more effective and faster relief for gut-related issues compared to standard treatments.

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

This trial will evaluate the effects of different active products on gut health. Research has shown that Active Product 1, one of the treatments in this trial, improves gut health by boosting good bacteria like bifidobacteria and lactobacilli, with studies finding a 27% increase in these bacteria. Active Product 2 supports digestive health by strengthening the gut lining and reducing harmful bacteria. Active Product 3 is linked to better bowel movements and fewer stomach issues, leading to improved stool consistency. Active Product 4 effectively reduces bloating and stomach pain while improving the balance of gut bacteria. Finally, Active Product 5 helps maintain a healthy gut environment and may relieve symptoms like depression, which can sometimes relate to gut health.14678

Who Is on the Research Team?

SH

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

Adults over 21 in the U.S. seeking to improve GI health, willing to take an unknown product (active or placebo), and not currently pregnant, trying to become pregnant, breastfeeding, or enrolled in another trial. Excludes heavy drinkers and those on certain medications.

Inclusion Criteria

Resides in the United States
Has the opportunity for at least 30% improvement in their primary health outcome
I am 21 years old or older.
See 1 more

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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health and wellness products or placebo for GI health assessment

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

  • Active Product 1
  • Active Product 2
  • Active Product 3
  • Active Product 4
  • Active Product 5
  • GI Product Placebo Control
Trial Overview The study is testing six products' effects on gastrointestinal health: five active wellness products versus a placebo. Participants won't know which they're receiving in this randomized, double-blind trial.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 5Experimental Treatment1 Intervention
Group II: Active Product 4Experimental Treatment1 Intervention
Group III: Active Product 3Experimental Treatment1 Intervention
Group IV: Active Product 2Experimental Treatment1 Intervention
Group V: Active Product 1Experimental Treatment1 Intervention
Group VI: 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

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39352252/
a randomized, double-blind, placebo-controlled clinical trialConclusions: AG1R can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality ...
Efficacy and safety of a gut health product (Actbiome) ...The Actbiome group showed 27.16% and 23.97% increase in fecal bifidobacteria and fecal lactobacilli count from screening stage to end of study respectively, ...
AG1® | Research StudiesAG1 Next Gen has been studied across multiple clinical trials, consistently demonstrating its effectiveness in closing common nutrient gaps and supporting gut ...
Health Products for Gut Health · Info for ParticipantsTrial Overview The study tests a new wellness product (Radicle GI Health Active Study Product 1.1) against a placebo to see if it improves gastrointestinal ...
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 ...
Risk and Safety of Probiotics - PMC - PubMed CentralProbiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials.
Efficacy and Safety of Probiotic Products for Digestive HealthThe objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive ...
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.
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