Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Conditions

• Gastrointestinal Health

Eligibility Criteria

Sex

ALL

Age

25 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

Start date

Nov 18, 2022

Status verified

Jan 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Placebo
  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
  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.
• Active Comparator: Viome's condition-based supplements
  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.

Primary Outcome Measure

Efficacy of VIOME's designed condition based supplements (VCS) [ Time Frame: ~4 months ]

Central Contacts

• Mory Mehrtash
  (425) 300-6933
  [email protected]
• Momchilo Vuyisich
  (425) 300-6933
  [email protected]

Locations (1)

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