Status:
RECRUITING
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders
Lead Sponsor:
Viome
Conditions:
Mental Health Issue
Depression
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
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 tw...
Detailed Description
Participants who meet the eligibility criteria are randomized into any of the two study arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm. Placebo and Viome's Precis...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06502717
Start Date
July 8 2024
End Date
December 1 2025
Last Update
January 29 2025
Active Locations (1)
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1
Viome Life Sciences
Bothell, Washington, United States, 98011