Clinical Research Studies




Introduction


The dominant medical-healthcare industrial paradigm is rewarded for the management of the symptoms of chronic disease, not the prevention or cure of them. Additionally, Viome sees a big gap between clinical studies and real-world applications that would directly benefit society, making incredible discoveries in technology, medicine, and science available to everyone at a faster rate.


Our comprehensive clinical research program has already enrolled more than 10,000 study participants in more than 20 chronic disease areas. Our clinical research programs generate accurate clinical and molecular data from people with different conditions and healthy participants. Using artificial intelligence and machine learning we gain a deeper insight into the root causes of chronic diseases. The goals of VLS clinical research programs are to develop:


  • Better diagnostic tests that can identify early signs and symptoms of diseases, so we can prevent the disease, instead of managing the symptoms.

  • Find new molecular markers of disease.

  • Better companion diagnostic tests, which will help identify the best choice of therapy.

  • Precision nutritional therapies that include diet and supplements and are solely based on the high-resolution data obtained from each person, and not generic recommendations for everyone.



Study Pipeline


Viome’s pipeline includes diagnostic and therapeutics development. Our starting point is the digitized data set from samples. If a signal or association is seen, we progress to further validation and development of diagnostics and/or therapeutics.


Active Studies


V-197 Study: Efficacy of Viome’s Precision Nutrition Program Towards Reducing HbA1c

Study description

Type 2 diabetes (T2D) is a highly prevalent chronic disease characterized by an imbalance in blood glucose and elevated HbA1c levels. Prediabetes often progresses to T2D without lifestyle changes or other interventions. Lowering HbA1c levels is associated with improved outcomes and reduced incidence of the complications that are associated with T2D. At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to reduce HbA1c levels. The primary objective of this clinical trial is to test if our personalized nutritional recommendations and/or supplements can reduce HbA1c levels resulting in improved outcomes for type 2 diabetics and prediabetics.

V-211.1 clinical trial: testing the efficacy of personalized nutrition to improve gastrointestinal health

Study description

The cause of irritable bowel syndrome (IBS) is not understood, but alterations in the gut microbiome have been observed and hypothesized to be a leading cause. Current treatment options for IBS focus largely on the management of symptoms but fail to address the underlying issues related to the microbiome. At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to reduce gastrointestinal symptoms, such as abdominal pain, cramping, bloating, diarrhea, and constipation. The primary objective of this clinical trial is to test if nutrition recommendations and/or supplements can help improve these gastrointestinal symptoms.

V-211.2 clinical trial: testing the efficacy of personalized nutrition to improve metabolic health

Study description

Metabolic conditions, such as obesity and type 2 diabetes are mostly caused by specific alterations in the composition and activity of the gut microbiome. At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to reduce weight by providing a diet that works with the individual’s gut microbiome. The primary objective of this clinical trial is to test if nutrition recommendations and/or supplements can help improve the signs and symptoms of metabolic health.

V-211.3 clinical trial: testing the efficacy of personalized nutrition to improve mental health

Study description

Mental health is dominated by depression, a chronic disease with high prevalence in the human population and a leading cause of human disability. Published results on the connection between diet and depression are conflicting, and pharmaceutical approaches are often not effective and can cause severe side effects, including suicide. At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to improve mental health by providing a diet that works with the individual’s gut microbiome. The primary objective of this clinical trial is to test if nutrition recommendations and/or supplements can help improve the signs and symptoms of mental health.

V-304 Study: The role of gut microbiome in the onset of IBD flares

Study description

Despite great strides in medicine, we still do not understand what causes the onset or flares of Inflammatory Bowel Disease (IBD). Many therapies available today are meant to treat the symptoms of the disease, but they are not great at disease prevention or cure. Studies have shown that our environment may play a strong role in the disease activity of IBD, including evidence that specific combinations of food and gut microorganisms may contribute to the disease and its flares. The goal of this study is to investigate the roles of nutrition and the microbiome in IBD flares. By participating in the study, you are helping to build the foundations of preventative medicine via better understanding of the gut microbiome and its effect on IBD.


What we ask of you:

Complete online health surveys and collect samples at home once a month during remission and once a week during a flare. There are no clinic or hospital visits required. You will be asked to collect stool, finger-prick blood, and saliva samples. The collection kits, instructions, and prepaid return mailers will be sent to you.


What you receive:

You may receive up to $200 for participating in this study. The study stipends will be provided as Amazon gift cards. A $100 gift card will be e-mailed to you 6 months after enrollment in the study if you have collected and returned your samples and completed your health surveys. A second $100 gift card will be sent to you 12 months after enrollment in the study if you have collected and returned your samples and completed your health surveys.


V-174 Study: Longitudinal Analysis of the Vaginal Microbiome

Study description

The purpose of this study is to measure the compositional and functional changes in the vaginal microbiome and vaginal mucosa. We will use the cutting edge metatranscriptomic technology to analyze vaginal samples from women collected at six time points across two menstrual cycles.


Research participants are expected to:

  • Answer short online surveys, including your health 

  • Collect 3 vaginal swab samples per day for 3 days in one menstrual cycle and 3 vaginal swab samples for 3 days in the second menstrual cycle. We will provide you with at-home collection kits and prepaid mailers.


Why participate:

  • You will receive a $50 Amazon gift card if you collect all samples and complete all study questionnaires

  • Once we analyze your samples, you will receive a list of all microorganisms we identified


V-249 Study: The role of microbiome in Fibromyalgia

Study description

This is a collaborative study with the University of Sydney that is recruiting patients in Auckland, New Zealand. The purpose of this study is to gather detailed information about digestive function, gut bacteria and their by-products as well as a range of symptoms affecting women with fibromyalgia and compare them to women without fibromyalgia. This study is only recruiting adult women who are either healthy or meet ACR2016 criteria for fibromyalgia and age & gender-matched controls.


V-168 study: Inflammatory Bowel Disease (IBD) Research Study

Study description

Despite great strides in medicine, we still do not understand what causes the onset or flares of Inflammatory Bowel Disease (IBD). Many therapies available today are meant to treat the symptoms of the disease, but they are not great at disease prevention or cure. Studies have shown that our environment may play a strong role in the disease activity of IBD, including evidence that specific combinations of food and gut microorganisms may contribute to the disease and its flares. The goal of this study is to investigate the roles of nutrition and the microbiome in IBD flares. By participating in the study, you are helping to build the foundations of preventative medicine via better understanding of the gut microbiome and its effect on IBD.


This study is only recruiting patients at the Center for Digestive Health in Orlando, FL.

V-242 Study: The role of the microbiome in colorectal cancer onset and progression

Study description

The goal of this research study is to identify the root causes of colorectal cancer (CRC) onset and progression. Despite great strides in medicine and cancer therapy, there are no effective preventative therapies. Research has shown that our genetics plays a minor role in the CRC onset and progression; the major role is played by the gut microbiome, our immune system and nutrition. However, the specific combination of nutrients, inflammatory signals and gut microbes that can cause CRC has not been identified. In this study, participants will be followed from cancer diagnosis for several years. During this time, several samples (stool, blood, saliva, urine, and tissue biopsies) will be collected at multiple time points. These samples will be analyzed using metatranscriptomic, genomic, and proteomic methods to generate vast amounts of data about each participant’s physiology, with the specific focus on microbiome-human interactions. All medical records will also be collected. Machine learning will be used to identify human and microbial determinants of CRC onset and progression.


The study is only recruiting patients at specific study sites.


Completed Studies


V-150 Study: Role of the gut microbiome in Ankylosing Spondylitis (AS / AxSpA)

Study description

Despite great strides in Medicine, we still do not understand what causes flares in patients with Ankylosing Spondylitis (AS), also known as Axial Spondyloarthropathy (AxSpA). Therefore, the only therapies available today are meant to slow down the disease, not stop it or help patients heal. Research has shown that our genetics does not define whether we are in remission or having a flare. Instead, studies have shown that our environment may play a stronger role, including evidence that specific combinations of food and gut microorganisms may contribute to the disease and its flares. The goal of this study is to better understand the root causes of AS flares.

V-109 Study: Predicting the glycemic response to food using the Viome Gut Intelligence test

Study description

The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with postprandial glycemic response.

V-202.3 Covid-19 Wellness Survey: Understand the role of the microbiome in health and wellness during the SARS-CoV-2 outbreak.

Study description

The goal of this study is to determine the effects of SARS-CoV-2, the virus that causes COVID-19, on general health and wellness. This brief survey asks questions about ones’ general health, symptoms one may have experienced, and nutritional habits.

V-179 study: Understanding adherence to Viome’s personalized nutrition program and improvements in general wellness.

Study description

The goal of this study is to understand how well customers follow their results and recommendations (R&R) to define an adherence score and to determine how adherence to Viome R&R improves general well-being. This study is currently only available to Viome customers.

V-146 Study: Understanding the role of the microbiome in autoimmune diseases

Study description

The goal of this study is to better understand the role of the microbiome in autoimmune disease progression and the molecular features that may contribute to disease relapse (flares) and to determine if there are specific microbes found in the microbiome that may contribute to disease activity. This study is currently only available to Viome customers.

V-136 study: Understanding the role of the microbiome in the prediction of diabetes and people's risk of developing diabetes.

Study description

The goal of this study is to determine if the microbiome can be predictive of an individual’s risk to developing Type II Diabetes. This study is currently only available to Viome customers.

V-118/V112 Study: Understanding gut-brain interactions

Study description

The gut microbiome has been associated with cognition as well as many different neurological diseases and disorders. This study will seek to better understand the connection between the gut and the brain (the gut-brain axis). This study is currently only available to Viome customers.


Upcoming Studies