Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
Viome Life Sciences
Bothell, Washington, United States, 98011
Actively Recruiting
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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