Actively Recruiting
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
Led by Viome · Updated on 2025-01-29
150
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Signed and dated informed consent prior to any trial-specific procedures
- Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (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
- Women who are pregnant (current or planned in the next 4 months), or breastfeeding
- 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 changes in the previous 1 month
- IBD diagnosis
- Use of investigational drugs, products or devices within 1 month prior to and 4 months after the trial start
- Cancer therapy within the previous 1 year
- Major surgery in the last 6 months or planned in the next 4 months
- Prescribed any drug(s) that may interact with the supplement formulations
- Any medical condition or allergy that may interact with or prevent healthy supplement consumption
- Allergies to any study-specific supplement ingredients
- Currently on a specific diet: FODMAP, KETO, PALEO
- Gastrointestinal diseases including esophagitis, celiac disease, GI malignancy or obstruction, peptic ulcer, duodenal or gastric ulcer disease
- 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
3
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