Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions
Viome
Summary
US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.
Description
Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm. Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.
Eligibility
- Age range
- 25–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Resident of the United States * Females and males ages 25-75 (inclusive) * Able to speak and read English * No unexplained weight loss, fevers, anemia, or blood in stool * 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. * Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (inclusive) Exclusion criteria * Unwilling to change current diet * Prior use of Viome products or services * Antibiotic use in the previous 4 weeks * Women who…
Interventions
- Combination ProductVIOME Precision Nutrition Program
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
- Dietary SupplementVIOME-designed condition-based supplements
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Location
- Viome Life SciencesBothell, Washington