Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Not Applicable

Recruiting

• Conditions: Gastrointestinal Health
• Interventions: Dietary Supplement: VIOME-designed condition-based supplements; Combination Product: VIOME Precision Nutrition Program

• Registration Number: NCT05465629
• Lead Sponsor: Viome

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-20
• Study Start: 2022-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viome's condition-based supplements	VIOME-designed 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.
Viome's Precision Nutrition Program	VIOME 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.

Primary Outcome Measures

Name	Time	Method
Efficacy of VIOME Precision Nutrition Program (VPNP)	~4months	Number of participants that show an improvement in GI health compared to baseline survey assessment.
Efficacy of VIOME's designed condition based supplements (VCS)	~4 months	Number of participants that show an improvement in GI health compared to baseline survey assessment.

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States