2100 Participants Needed

Health Products for Gut Health

SM
P
Overseen ByPauli

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products, such as anticoagulants, antihypertensives, and others listed in the exclusion criteria. If you are on any of these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Radicle GI Health Active Study Product 1.1 for gut health?

The research highlights the importance of assessing health-related quality of life (HRQoL) and patient-reported outcomes in gastrointestinal (GI) treatments. While specific data on Radicle GI Health Active Study Product 1.1 is not provided, studies show that probiotics, like those used in similar treatments, can improve GI well-being and symptoms in individuals with mild GI discomfort.12345

How is the Radicle GI Health Active Study Product 1.1 treatment different from other gut health treatments?

Radicle GI Health Active Study Product 1.1 is unique because it likely involves a combination of functional foods or nutraceuticals (food-derived products with health benefits) that target gut health, potentially altering gut microflora and improving gastrointestinal functions, unlike standard medications that may not address these aspects.678910

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Research Team

EK

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

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.

Inclusion Criteria

I am 21 years or older and understand my participation may involve sex-specific aspects.
Resides in the United States
I want to improve my bowel habits and reduce stomach issues.
See 2 more

Exclusion Criteria

Unable to read and understand English
Unable to provide a valid US shipping address and mobile phone number
Reports current enrollment in another clinical trial
See 7 more

Timeline

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

Treatment Details

Interventions

  • Radicle GI Health Active Study Product 1.1
Trial 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 health and related outcomes. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product.
Participant Groups
18Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 7.4.1Experimental Treatment1 Intervention
GI Health Product Form 7.4 - active product 1
Group II: Active Product 7.3.1Experimental Treatment1 Intervention
GI Health Product Form 7.3 - active product 1
Group III: Active Product 7.2.1Experimental Treatment1 Intervention
GI Health Product Form 7.2 - active product 1
Group IV: Active Product 7.1.1Experimental Treatment1 Intervention
GI Health Product Form 7.1 - active product 1
Group V: Active Product 5.1Experimental Treatment1 Intervention
GI Health Product Form 5 - active product 1
Group VI: Active Product 4.1Experimental Treatment1 Intervention
GI Health Product Form 4 - active product 1
Group VII: Active Product 3.1Experimental Treatment1 Intervention
GI Health Product Form 3 - active product 1
Group VIII: Active Product 2.1Experimental Treatment1 Intervention
GI Health Product Form 2 - active product 1
Group IX: Active Product 1.1Experimental Treatment1 Intervention
GI Health Product Form 1 - active product 1
Group X: Placebo Control 2Placebo Group1 Intervention
GI Health Product Form 2 - control
Group XI: Placebo Control 7.4.0Placebo Group1 Intervention
GI Health Product Form 7.4 - control
Group XII: Placebo Control 5Placebo Group1 Intervention
GI Health Product Form 5 - control
Group XIII: Placebo Control 4Placebo Group1 Intervention
GI Health Product Form 4 - control
Group XIV: Placebo Control 3Placebo Group1 Intervention
GI Health Product Form 3 - control
Group XV: Placebo Control 1.1Placebo Group1 Intervention
GI Health Product Form 1 - control
Group XVI: Placebo Control 7.1.0Placebo Group1 Intervention
GI Health Product Form 7.1- control
Group XVII: Placebo Control 7.3.0Placebo Group1 Intervention
GI Health Product Form 7.3 - control
Group XVIII: Placebo Control 7.2.0Placebo Group1 Intervention
GI Health Product Form 7.2 - control

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials
24
Recruited
46,200+

Findings from Research

A new patient-reported outcome instrument for chronic gastrointestinal diseases was developed based on data from 274 respondents in a clinical investigation across 4 hospitals in Beijing.
The initial version of the instrument includes 35 items, with some modifications needed, indicating that further refinement and testing with larger sample sizes are necessary for optimal effectiveness.
[Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: item selection].Wang, P., Tang, XD., Liu, BY., et al.[2019]
In a study involving 197 adult women over 4 weeks, those consuming a probiotic fermented milk reported significant improvements in gastrointestinal (GI) well-being compared to a control group, indicating the efficacy of probiotics in enhancing digestive health.
The study validated a single-item questionnaire as an effective tool for measuring GI well-being, showing that improvements in GI well-being correlated with fewer digestive symptoms and better health-related quality of life.
Gastrointestinal well-being in subjects reporting mild gastrointestinal discomfort: characteristics and properties of a global assessment measure.Guyonnet, D., Naliboff, B., Rondeau, P., et al.[2019]
Patient-rated outcomes, especially for conditions like gastroesophageal reflux disease and dyspepsia, are crucial for evaluating treatments for gastrointestinal disorders, but there is a lack of comprehensive research in areas like gastroparesis.
Current symptom scales for GI disorders are underdeveloped and not systematically evaluated, highlighting the need for better assessment tools that combine both clinician and patient perspectives in future clinical trials.
Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: a review and synthesis of the literature.Rentz, AM., Battista, C., Trudeau, E., et al.[2018]

References

[Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: item selection]. [2019]
Gastrointestinal well-being in subjects reporting mild gastrointestinal discomfort: characteristics and properties of a global assessment measure. [2019]
Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: a review and synthesis of the literature. [2018]
Health-related quality of life, patient outcome, and managed care: the road ahead. [2019]
Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. [2022]
Herbal formula improves upper and lower gastrointestinal symptoms and gut health in Australian adults with digestive disorders. [2021]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. [2018]
A Brief Review of Nutraceutical Ingredients in Gastrointestinal Disorders: Evidence and Suggestions. [2020]
Daily consumption of a synbiotic yogurt decreases energy intake but does not improve gastrointestinal transit time: a double-blind, randomized, crossover study in healthy adults. [2022]
The role of functional foods, nutraceuticals, and food supplements in intestinal health. [2021]
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