Health Products for Gut Health

Overseen By Pauli

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

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

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

2100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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.

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

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

Group I: Active Product 7.4.1 Experimental Treatment 1 Intervention

GI Health Product Form 7.4 - active product 1

Group II: Active Product 7.3.1 Experimental Treatment 1 Intervention

GI Health Product Form 7.3 - active product 1

Group III: Active Product 7.2.1 Experimental Treatment 1 Intervention

GI Health Product Form 7.2 - active product 1

Group IV: Active Product 7.1.1 Experimental Treatment 1 Intervention

GI Health Product Form 7.1 - active product 1

Group V: Active Product 5.1 Experimental Treatment 1 Intervention

GI Health Product Form 5 - active product 1

Group VI: Active Product 4.1 Experimental Treatment 1 Intervention

GI Health Product Form 4 - active product 1

Group VII: Active Product 3.1 Experimental Treatment 1 Intervention

GI Health Product Form 3 - active product 1

Group VIII: Active Product 2.1 Experimental Treatment 1 Intervention

GI Health Product Form 2 - active product 1

Group IX: Active Product 1.1 Experimental Treatment 1 Intervention

GI Health Product Form 1 - active product 1

Group X: Placebo Control 2 Placebo Group 1 Intervention

GI Health Product Form 2 - control

Group XI: Placebo Control 7.4.0 Placebo Group 1 Intervention

GI Health Product Form 7.4 - control

Group XII: Placebo Control 5 Placebo Group 1 Intervention

GI Health Product Form 5 - control

Group XIII: Placebo Control 4 Placebo Group 1 Intervention

GI Health Product Form 4 - control

Group XIV: Placebo Control 3 Placebo Group 1 Intervention

GI Health Product Form 3 - control

Group XV: Placebo Control 1.1 Placebo Group 1 Intervention

GI Health Product Form 1 - control

Group XVI: Placebo Control 7.1.0 Placebo Group 1 Intervention

GI Health Product Form 7.1- control

Group XVII: Placebo Control 7.3.0 Placebo Group 1 Intervention

GI Health Product Form 7.3 - control

Group XVIII: Placebo Control 7.2.0 Placebo Group 1 Intervention

GI Health Product Form 7.2 - control

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The healthcare system is shifting towards a model that emphasizes not just the safety and efficacy of treatments, but also their cost-effectiveness and impact on patients' quality of life, reflecting a more consumer-driven approach.

Outcomes research in gastrointestinal (GI) diseases is growing, highlighting the need for gastroenterologists to engage in this research to improve care quality and achieve cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life, patient outcome, and managed care: the road ahead. Fullerton, S., Gitnick, G.[2019]

A new Gastrointestinal Quality of Life Index (GIQLI) has been developed and validated through three phases involving a total of 462 patients, making it a reliable tool for assessing quality of life in individuals with gastrointestinal diseases.

The GIQLI is a bilingual questionnaire with 36 questions that has been tested for reproducibility and responsiveness, indicating it is ready for use in both clinical practice and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Eypasch, E., Williams, JI., Wood-Dauphinee, S., et al.[2022]

The NC Gut Relief Formula, containing various herbs and nutrients, significantly improved gastrointestinal symptoms and overall gut health in 43 adults over a 16-week study, with reductions in symptoms like indigestion and abdominal pain by 60%-80%.

Participants also experienced enhanced quality of life, with many reducing or eliminating the need for proton pump inhibitors and successfully reintroducing previously problematic foods into their diets without worsening symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal formula improves upper and lower gastrointestinal symptoms and gut health in Australian adults with digestive disorders. Ried, K., Travica, N., Dorairaj, R., et al.[2021]

In a study of 20 celiac disease patients, the use of Native-complex Fucus jelly over 2 months significantly improved stool consistency and frequency, with 70% of patients achieving daily bowel movements by the end of the study.

The functional food also positively impacted gut microbiota, correcting dysbiosis and enhancing intestinal health, which is often compromised in patients following a long-term gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. Tkachenko, EI., Oreshko, LS., Sitkin, SI., et al.[2018]

Recent studies highlight the connection between specific diets and a lower incidence of gastrointestinal diseases, suggesting that certain foods can positively impact gut health.

The review emphasizes the potential preventive and therapeutic roles of food-derived ingredients, which are being studied and some of which are already available as dietary supplements for gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Review of Nutraceutical Ingredients in Gastrointestinal Disorders: Evidence and Suggestions. Gao, X., Liu, J., Li, L., et al.[2020]

In a study involving 65 healthy adults, daily consumption of 200 g of synbiotic yogurt did not significantly change gastrointestinal transit time or symptoms, indicating it was well tolerated.

The synbiotic yogurt led to a reduction in overall energy intake, particularly in participants with short gastrointestinal transit times, suggesting potential benefits for dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Tulk, HM., Blonski, DC., Murch, LA., et al.[2022]

Nutraceuticals and functional foods have the potential to improve health issues related to modern diets, particularly in the gastrointestinal tract, by influencing gut microflora and supporting nutritional and immune functions.

The paper emphasizes the need for advanced functional cell models and analytical tools to better understand how these foods can positively impact health and address diseases like obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of functional foods, nutraceuticals, and food supplements in intestinal health. Cencic, A., Chingwaru, W.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

[Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: item selection]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal well-being in subjects reporting mild gastrointestinal discomfort: characteristics and properties of a global assessment measure. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: a review and synthesis of the literature. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life, patient outcome, and managed care: the road ahead. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Brief Review of Nutraceutical Ingredients in Gastrointestinal Disorders: Evidence and Suggestions. [2020]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The role of functional foods, nutraceuticals, and food supplements in intestinal health. [2021]