Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
NCT06502717

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

Led by Viome · Updated on 2025-01-29

150

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resident of the United States
  • Female or male aged 25 to 75 years (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
  • Signed and dated informed consent prior to any trial-specific procedures
  • PHQ9 score between 5 and 24 (inclusive)
Not Eligible

You will not qualify if you...

  • Unwilling to change current diet
  • Prior use of Viome products or services
  • Antibiotic use in the previous 4 weeks
  • Pregnant, planning pregnancy in the next 4 months, breastfeeding, or less than 90 days postpartum
  • 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
  • Diagnosis of inflammatory bowel disease
  • Major psychiatric or DSM-4 diagnosis (e.g., schizophrenia, bipolar disorder, PTSD, OCD)
  • Use of investigational drugs, products, or devices within 1 month before and 4 months after trial start
  • 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 FODMAP, KETO, or PALEO diet
  • Recent suicidal thoughts
  • Gastrointestinal diseases including esophagitis, celiac disease, GI malignancy or obstruction, peptic ulcer disease, duodenal or gastric ulcer disease
  • History of GI surgery except appendectomy and benign polypectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Viome Life Sciences

Bothell, Washington, United States, 98011

Actively Recruiting

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Research Team

M

Mory Mehrtash

CONTACT

M

Momchilo Vuyisich

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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