Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
Trial Parameters
Brief 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.
Eligibility Criteria
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 are pregnant (current or planned in the next 4 months), or breastfeeding * \< 90 days postpartum * Active infection * Unable or unwilling to use Viome's App on an iPhone or Android smartphone * Significant diet or lifestyle changes in the previous 1 month * IBD diagnosis * Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial * Cancer the