Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders

Description

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.

Conditions

Mental Health Issue, Depression, Anxiety

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Study Overview

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Study Details

Study overview

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders

Condition
Mental Health Issue
Intervention / Treatment

-

Contacts and Locations

Bothell

Viome Life Sciences, Bothell, Washington, United States, 98011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * PHQ9 score of 5-24 (inclusive)
  • * Unwilling to change their current diet
  • * Prior use of Viome products or services
  • * Antibiotic use in the previous 4 weeks
  • * Pregnancy (current or planned in the next 4 months)
  • * \< 90 days postpartum
  • * Breast feeding
  • * Active infection
  • * Unable or unwilling to use Viome's App on an iPhone or Android smartphone
  • * Significant diet or lifestyle change in the previous 1 month
  • * IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
  • * 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
  • * Allergies to any supplement ingredients listed in the screening survey
  • * Currently on a specific diet: FODMAP, KETO, PALEO
  • * Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
  • * Gastrointestinal disease including:
  • * GI surgery except:
  • * Appendectomy and benign polypectomy
  • * Esophagitis
  • * Celiac disease
  • * GI malignancy or obstruction
  • * Peptic Ulcer Disease
  • * Duodenal or gastric ulcer disease

Ages Eligible for Study

25 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viome,

Momchilo Vuyisich, PRINCIPAL_INVESTIGATOR, Viome

Study Record Dates

2025-12