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Dietary Supplement

Health Products for Gut Health

N/A
Recruiting
Led By Emily K. Pauli, PharmD
Research Sponsored by Radicle Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

This trial will test how health and wellness products affect gut health and overall health outcomes in a fair and unbiased manner.

Who is the study for?
This trial is for individuals experiencing gastrointestinal disorders, abdominal pain, or digestion issues. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to join.
What is being tested?
The study tests a new wellness product (Radicle GI Health Active Study Product 1.1) against a placebo to see if it improves gastrointestinal health and related outcomes. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product.
What are the potential side effects?
Potential side effects are not listed but may include reactions typical of GI treatments such as nausea, discomfort, or changes in bowel habits. The exact side effects will depend on the nature of the active study product.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to take a study drug without knowing if it's active or a placebo.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have serious heart, liver, or kidney conditions that could make the study unsafe for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in GI (Gastrointestinal) Health (1)
Change in GI (Gastrointestinal) Health (2)
Change in GI (Gastrointestinal) Health (3)
+3 more
Secondary study objectives
Change in GI-related Quality of Life (QOL)
Change in feelings of anxiety
Change in mood (emotional distress-depression)
+9 more
Other study objectives
Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

Trial Design

12Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 7.1Experimental Treatment1 Intervention
GI Health Product Form 7 - active product 1
Group II: Active Product 5.1Experimental Treatment1 Intervention
GI Health Product Form 5 - active product 1
Group III: Active Product 4.1Experimental Treatment1 Intervention
GI Health Product Form 4 - active product 1
Group IV: Active Product 3.1Experimental Treatment1 Intervention
GI Health Product Form 3 - active product 1
Group V: Active Product 2.1Experimental Treatment1 Intervention
GI Health Product Form 2 - active product 1
Group VI: Active Product 1.1Experimental Treatment1 Intervention
GI Health Product Form 1 - active product 1
Group VII: Placebo Control 2Placebo Group1 Intervention
GI Health Product Form 2 - control
Group VIII: Placebo Control 1Placebo Group1 Intervention
GI Health Product Form 1 - control
Group IX: Placebo Control 5Placebo Group1 Intervention
GI Health Product Form 5 - control
Group X: Placebo Control 4Placebo Group1 Intervention
GI Health Product Form 4 - control
Group XI: Placebo Control 3Placebo Group1 Intervention
GI Health Product Form 3 - control
Group XII: Placebo Control 7Placebo Group1 Intervention
GI Health Product Form 7- control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radicle GI Health Active Study Product 3.1 Usage
2023
N/A
~2180
Radicle GI Health Active Study Product 1.1 Usage
2023
N/A
~2180
Radicle GI Health Active Study Product 2.1 Usage
2023
N/A
~2180

Find a Location

Who is running the clinical trial?

Radicle ScienceLead Sponsor
21 Previous Clinical Trials
42,953 Total Patients Enrolled
Emily K. Pauli, PharmDPrincipal InvestigatorRadicle Science, Inc
17 Previous Clinical Trials
35,426 Total Patients Enrolled
~933 spots leftby Oct 2025
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.
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