Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions

Conditions
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Gastrointestinal Health

Intervention / Treatment
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* Combination Product: VIOME Precision Nutrition Program
* Dietary Supplement: VIOME-designed condition-based supplements


Participation Criteria
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Eligibility Criteria
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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 therapy within the previous 1 year Major surgery in the last 6 months or planned in the next 4 months Prescribed any drug(s) that may interact with the supplement formulations Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements Allergies to any study-specific supplement ingredients Currently on a specific diet: FODMAP KETO PALEO - Gastrointestinal disease including: Esophagitis Celiac disease GI malignancy or obstruction Peptic ulcer Duodenal or gastric ulcer disease GI surgery except: Appendectomy and benign polypectomy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br>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. | |
| Active Comparator: Viome's Precision Nutrition Program<br>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. | Combination Product: VIOME Precision Nutrition Program<br>* Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.<br>* Other names: VPNP;|
| Active Comparator: Viome's condition-based supplements<br>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. | Dietary Supplement: VIOME-designed condition-based supplements<br>* Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.<br>* Other names: VCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of VIOME's designed condition based supplements (VCS) | Number of participants that show an improvement in GI health compared to baseline survey assessment. |  4 months | 
| Efficacy of VIOME Precision Nutrition Program (VPNP) | Number of participants that show an improvement in GI health compared to baseline survey assessment. |  4months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Diarrhea, Constipation, Bloating, Gastroesophageal, Viome, Nutrition, Supplements, VPNP, Viome precision nutrition program, Reflux, Diet, Microbiome, Biome, Gastrointestinal