GI Health Product for Diarrhea

Overseen By Susan Hewlings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

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

Disqualifiers: Pregnancy, Cardiac dysfunction, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new GI health product designed to alleviate diarrhea. Participants will receive either the active product or a placebo (a harmless pill with no active ingredients) to evaluate the product's effectiveness. It is suitable for adults in the U.S. who have experienced diarrhea and believe they might see at least a 30% improvement with treatment. Participants must be willing to take the product without knowing whether it is the active product or a placebo. As an unphased trial, this study provides participants the opportunity to contribute to important research that could lead to new treatment options for GI health.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking certain medications that could interact with the study product, such as blood thinners, blood pressure medications, and antidepressants, among others. If you're on any of these, you may need to stop them to participate.

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

In previous studies, participants using GI Health Active Product 1 demonstrated promising safety results. Research indicates that the main ingredient, Bacillus coagulans MTCC 5856, was well-tolerated by people with diarrhea. No major side effects were reported, suggesting it could be a safe option for improving gut health.

Additionally, GI Health Active Product 1 includes loperamide, a common ingredient for treating diarrhea. The FDA has already approved loperamide for this condition in other products, confirming its known safety record.

These findings suggest the treatment is safe for use. However, individuals should consider their own health and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard of care for diarrhea, which typically includes options like loperamide and bismuth subsalicylate, the GI Health Active Product 1 offers a new approach. Researchers are excited about this treatment because it may target gut health differently, potentially addressing the root causes of diarrhea rather than just alleviating symptoms. This unique approach could lead to more effective and longer-lasting relief for patients, setting it apart from existing treatments.

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

Research shows that GI Health Active Product 1, which participants in this trial may receive, might help manage diarrhea. Studies have found that probiotics and synbiotics, like those in this product, can regulate stools and shorten the duration of diarrhea. This suggests they might help the digestive system return to normal more quickly. Evidence from clinical research also indicates that these products can slightly reduce the risk of diarrhea, especially in certain groups like ICU patients. While results can vary among individuals, these findings offer promising insights into the potential benefits of this treatment for digestive health. ^{1 2 6 7 8}

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 experiencing GI issues like travelers' diarrhea, Morquio Syndrome, constipation, flatulence, and general diarrhea. Participants should be interested in testing health and wellness products' effects on their GI health.

Inclusion Criteria

Participant must have the opportunity for at least 30% improvement in their primary health outcome

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

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

Exclusion Criteria

Participant reports being pregnant, trying to become pregnant, or breastfeeding

Participant is unable to provide a valid US shipping address and mobile phone number

Participant reports current enrollment in another clinical trial

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 6 weeks, with self-reported data collected electronically

6 weeks

No in-person visits; all assessments are electronic

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• GI Health Active Product 1
• GI Health Product Placebo Control

Trial Overview The study tests two things: 'GI Health Active Product 1' against a placebo (a product with no active ingredients). It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product or placebo.

How Is the Trial Designed?

Group I: Active Product 1 Experimental Treatment 1 Intervention

GI Health Active Product 1

Group II: Placebo Control Placebo Group 1 Intervention

GI Health Product Placebo 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. Detailed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07212231

Radicle GI Health: A Study Assessing the Impact of ... This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7481057/

Efficacy of the Probiotic Probiotical Confirmed in Acute ... In conclusion, the synbiotic Probiotical was shown to enhance the normalization of stool consistency and reduce the duration of diarrhea. Two independently ...

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724015420

Meta-analysis The effectiveness of probiotics or synbiotics ... Probiotics or synbiotics appear to slightly reduce the incidence of diarrhea among ICU patients. However, this effect is considered statistically significant ...

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.report fda.report/DailyMed/46e3046f-0aea-4848-b5ab-bac4ff0c7f2e

DG HEALTH ANTI DIARRHEAL- loperamide hcl solution Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg. Purpose Anti-diarrheal. Use controls symptoms of diarrhea, including Travelers' Diarrhea.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4769834/

Bacillus coagulans MTCC 5856 supplementation in the ... Specific emphasis was given on the safety of B. coagulans MTCC 5856 in patients with diarrhea predominant IBS. The safety data of the study ...