Actively Recruiting
Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions
Led by Viome · Updated on 2025-01-29
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying gastrointestinal health in US residents who have gastrointestinal issues, focusing on irritable bowel syndrome (IBS) diagnosed by ROME IV criteria with specific symptom scores. The study evaluates the effects of Viome-designed condition-based supplements and the Viome Precision Nutrition Program compared to a placebo. This interventional trial aims to improve clinical outcomes related to gastrointestinal wellness over approximately four months. Participants are randomly assigned to one of three groups: a placebo group receiving inert capsules, a group receiving Viome's condition-based supplements tailored to overall health conditions, and a group receiving the Viome Precision Nutrition Program based on microbiome sample results. Each group may receive nutritional supplements, dietary recommendations, and coaching. The study is direct-to-participant and does not involve clinical sites, with some participants using a mobile app to support participation. During the trial, participants complete surveys and follow nutritional guidance as assigned. Researchers monitor the efficacy of both the condition-based supplements and the precision nutrition program over about four months. Participants must adhere to study instructions and use the Viome app as needed. The study assesses symptom improvements and dietary adherence while ensuring safety and participant compliance throughout the trial period.
CONDITIONS
Brief 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, as described in the recruitment letter
- 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 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
- Prescribed any drug(s) that may interact with the supplement formulations
- Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements
- Allergies to any study-specific supplement ingredients
- Currently on a specific diet: FODMAP, KETO, PALEO
- Gastrointestinal disease 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Approximately 4 months
Participants receive Viome-designed nutritional supplements and may follow dietary recommendations and coaching to improve gastrointestinal symptoms. This includes the control arm, condition-based supplements, or the precision nutrition program.
Regular visits or remote check-ins as coordinated through the mobile app
Trial Site Locations
Total: 1 location
1
Viome Life Sciences
Bothell, Washington, United States, 98011
Actively Recruiting
Research Team
M
Mory Mehrtash
M
Momchilo Vuyisich
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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