Clinical trials for natural products that target motion sickness, nausea/vomiting, the microbiome, and other signs of gut health
Digestive or "gut" health is one of the most important elements of health and wellness. Digestion is a complex process that our bodies are constantly undertaking, and the effects of digestion have a far reaching impact on multiple bodily systems.
Today's consumers recognize the importance of a healthy digestive system and want to face a wide range of situations with improved quality of life. Some consumers are eager to address short-term concerns such as motion sickness or morning sickness, while others want to invest in long-term health related goals by targeting the microbiome. Regardless of the ultimate goal, consumers have shown that gut health is a priority, and they're willing to invest in brands that can deliver proof of efficacy. A clinical trial with Franklin Health can deliver the evidence your brand needs to stand out in this crowded market.
Endpoints for Gut Health Studies
Gut health can involve a wide range of potential outcomes ranging from short-term and immediate effects to long-range gradual improvements. Normal, routine concerns such as morning sickness, motion sickness, or occasional nausea may only require 1-2 days of testing with very clear targeted outcomes, whereas more comprehensive improvements to the microbiome or the overall digestive system may require 3-4 months of daily intervention with complex stool tests to capture improvements.
Regardless of your primary effect, Franklin will create a custom trial for your product. Each product has unique needs, so your trial's specific endpoints will be determined through collaboration between your marketing goals and our research team, ensuring that they match your product's greatest effects. Our most commonly used endpoints include:
The digestion domain quantifies symptoms which affect the stomach and small intestine which can be reduced by gut enhancing products.
This construct measures stomach cramping, bloating, and other measures of discomfort caused by diet, lifestyle, or related factors.
This construct quantifies symptoms related to the large intestine and healthy elimination.
The brain-gut connection is powerful; this domain quantifies the effects of improved gut health on cognitive outcomes.
Inflammatory biomarkers from stool samples provide an indicator of the health of the stomach lining. Reduced inflammation is associated with improved gut health.
Short chain fatty acids are produced by fermentation of fiber in the gut and provide an indicator of gut regulation.
Secretory IgA (SIgA) levels provide an indicator of the efficacy of healthy gut microflora.
Through home-based stool sampling, our team quantifies the diversity of healthy bacteria in the gut as well as the quantity of healthy microbes.
Gut Health Clinical Trials
Many natural products have an effect on gut health and today's consumers are eager to see improvements in this important component of wellness. Capturing the improvements your product delivers requires multidisciplinary expertise to create a trial that is customized to feature the greatest effects your product can deliver.
Working with Franklin for a high quality clinical trial with a gut health outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:
- eliminates occasional indigestion
- improves gut health
- boosts the digestive system
- alleviates morning sickness
- diminishes the effects of motion sickness
- for relief of an upset stomach
Gut health trials can range from quick studies evaluating the effects of immediate relief from normal conditions such as motion sickness to long-term studies evaluating changes to the microbiome as a result of dietary supplements.
Because the digestive system plays a role on overall health and wellness, additional secondary or tertiary outcomes can boost the ROI of your trial. Outcomes such as stress, sleep, or immune function are often improved as a result of boosted gut health.
Questions About Gut-Health Trials
You know your product improves gut health; we'll help you prove it.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven."