Nutritional Programs for Gastrointestinal Health

Overseen By Momchilo Vuyisich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Antibiotics, Investigational drugs

Disqualifiers: Pregnancy, IBD, Cancer therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests nutritional programs to improve symptoms in people with stomach problems. Participants will be randomly assigned to one of three groups: one group receives VIOME-designed condition-based supplements, another receives the VIOME Precision Nutrition Program, and the last group receives placebo pills. The goal is to assess how these different approaches affect gastrointestinal health. The trial seeks U.S. residents with IBS, a condition causing stomach pain and bowel issues, who have not used Viome products before and are willing to follow trial instructions. As an unphased trial, this study provides a unique opportunity to explore innovative nutritional solutions for IBS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are prescribed drugs that may interact with the study supplements.

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

Studies have shown that Viome-designed supplements for specific conditions can sometimes cause side effects. For instance, one report noted that an individual developed hives after taking these supplements. While generally safe, some people might experience skin reactions.

Less detailed safety information is available for the Viome Precision Nutrition Program. This program creates personalized nutrition plans based on gut interactions with food, aiming to improve health with tailored advice.

Both treatments support gut health, but individual reactions can differ. It's important to consider this and consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for gastrointestinal issues, which often involve medications to reduce symptoms or dietary changes, the VIOME Precision Nutrition Program and condition-based supplements are tailored to an individual's unique microbiome and health needs. These treatments harness advanced technology to analyze each person's gut health and deliver personalized nutrition and supplement recommendations. Researchers are excited about these treatments because they offer a new level of customization and potential effectiveness by addressing the root cause of gastrointestinal issues rather than just alleviating symptoms. This personalized approach aims to optimize gut health and overall well-being, which could lead to more sustainable improvements for individuals.

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

Research has shown that Viome's special supplements and Precision Nutrition Program, both under study in this trial, aim to improve gut health by offering personalized nutrition based on individual gut bacteria. Participants in this trial may receive either Viome's condition-based supplements or the Precision Nutrition Program. Studies have found that these programs can help reduce stomach issues such as pain and cramping. The supplements and nutrition plans are tailored to each person's gut, potentially leading to better results. Early findings suggest that by addressing the specific needs of the gut, these treatments could effectively manage and improve digestive health. ^{1 2 6 7 8}

Who Is on the Research Team?

Momchilo Vuyisich

Principal Investigator

Viome

Are You a Good Fit for This Trial?

This trial is for US residents aged 25-75 with gastrointestinal issues, specifically IBS as per ROME IV criteria and an IBS-SSS score of 125-450. Participants must understand English and be willing to follow the study's instructions after signing a consent form. Those with unexplained weight loss, fevers, anemia, or blood in stool cannot join.

Inclusion Criteria

Able to speak and read English

Willing and able to follow the trial instructions, as described in the recruitment letter

Signed and dated informed consent prior to any trial-specific procedures

Exclusion Criteria

I currently have an infection.

Significant diet or lifestyle changes in the previous 1 month

I am not willing to change my current diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three arms and receive either placebo, Viome's condition-based supplements, or Viome's Precision Nutrition Program for gastrointestinal wellness

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIOME-designed condition-based supplements
• VIOME Precision Nutrition Program

Trial Overview

The Viome Nutritional Programs are being tested to see if they improve gastrointestinal health. Participants will complete a survey and then be randomly placed into one of three groups without visiting clinical sites. They'll either receive the VIOME Precision Nutrition Program or condition-based supplements designed by VIOME.

How Is the Trial Designed?

Group I: Viome's condition-based supplements Active Control 1 Intervention

Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Group II: Placebo Active Control 1 Intervention

Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Group III: Viome's Precision Nutrition Program Active Control 1 Intervention

Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Who Is Running the Clinical Trial?

Viome

Lead Sponsor

Trials

22

Recruited

37,600+

Published Research Related to This Trial

Diet plays a significant role in managing inflammatory bowel diseases (IBD), and personalized dietary strategies may help improve symptoms and nutritional status for individual patients.

The review emphasizes the need for tailored nutritional advice based on the unique clinical and molecular characteristics of IBD, suggesting that personalized approaches could lead to better management of inflammation and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Dietary Regimens for Inflammatory Bowel Disease: Current Knowledge and Future Perspectives. Wellens, J., Vissers, E., Matthys, C., et al.[2023]

Personalized nutrition (PN) interventions lead to greater improvements in dietary intake compared to generalized dietary advice, based on a systematic review of 11 randomized controlled trials involving 57 to 1488 participants across the US, Canada, and Europe.

The studies showed a low risk of bias and varied follow-up durations from 1 to 12 months, indicating that tailored dietary advice can be more effective, but further research is needed to explore different personalization methods and incorporate behavior-change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Jinnette, R., Narita, A., Manning, B., et al.[2023]

Current nutritional recommendations lack sufficient data for both group-level and individualized dietary guidance, highlighting a significant gap in the field.

Emerging technologies like genomics, proteomics, and metabolomics hold the potential to revolutionize personalized nutrition, but they are not yet widely utilized in practice, necessitating better education and interdisciplinary collaboration among nutritionists and scientists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized nutritional recommendations: do we have the measurements needed to assess risk and make dietary recommendations? Arab, L.[2008]

Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

Precision nutrition research highlights that individual responses to diets can vary significantly due to interactions between dietary factors and personal genetic makeups, which has implications for health outcomes like obesity and weight loss.

Emerging studies suggest that a comprehensive multiomics approach, including factors like the gut microbiome and biological rhythms, could enhance the prediction of how individuals respond to different diets, paving the way for personalized dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition for precision health: The time is now. Qi, L.[2022]

The BASIC language program effectively assesses nutritional status using anthropometric, immunological, and clinical data, allowing for a comprehensive evaluation of individual health.

This program not only streamlines the process of diagnosing nutritional issues but also aids in creating personalized diets, enhancing both accuracy and efficiency in nutritional management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A computer program for assessing nutritional status and diet preparation]. Rodríguez, MC., Rodríguez-Mariscal, MJ., Martínez, JA., et al.[2013]

The gut microbiota plays a crucial role in human health, influencing the balance between gut bacteria, nutrients, and the body's genetic and physiological factors, which can affect disease outcomes.

The concept of the 'gutome' highlights the importance of understanding host-microbiome interactions and how nutrigenomics can lead to significant advancements in biomedicine and public health policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The human gutome: nutrigenomics of the host-microbiome interactions. Dimitrov, DV.[2011]

The US Dietary Guidelines for Americans (DGA) have been in place for 40 years, yet many essential nutrients are still under-consumed, indicating a need for updated recommendations based on current evidence.

The paper suggests modernizing Dietary Reference Intakes (DRIs) for vitamins and minerals, particularly for vitamin K and magnesium, and establishing new DRIs for compounds like lutein and omega-3 fatty acids (EPA + DHA) to better support health and prevent deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Nutrient Deficiency-Opportunities to Improve Nutritional Status and Promote Health Modernizing DRIs and Supplementation Recommendations. McBurney, MI., Blumberg, JB., Costello, RB., et al.[2023]

A survey of 452 adults in Germany revealed that about 45% are open to genetic testing for personalized nutrition advice, indicating a strong interest in tailored dietary recommendations based on individual health risks.

Over 40% of participants expressed a willingness to purchase functional food products designed to reduce cardiovascular disease risk, suggesting a promising market for personalized nutrition solutions, although challenges in implementation remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer demand for personalized nutrition and functional food. Roosen, J., Bruhn, M., Mecking, RA., et al.[2022]

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