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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No 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. | |
| Viome's Precision Nutrition Program | Active Comparator | 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. |
|
| Viome's condition-based supplements | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIOME Precision Nutrition Program | Combination Product | Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. |
| 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 |
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Inclusion Criteria
Exclusion criteria
FODMAP KETO PALEO
- Gastrointestinal disease including: Esophagitis Celiac disease GI malignancy or obstruction Peptic ulcer Duodenal or gastric ulcer disease
Appendectomy and benign polypectomy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mory Mehrtash | Contact | (425) 300-6933 | studies@viome.com | |
| Momchilo Vuyisich | Contact | (425) 300-6933 | studies@viome.com |
| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Recruiting | Bothell | Washington | 98011 | United States |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D003967 | Diarrhea |
| D003248 | Constipation |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
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Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
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Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
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| VIOME-designed condition-based supplements | Dietary Supplement | Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. |
|
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| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |