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Dietary Supplement

Viome's condition-based supplements for Gastrointestinal Health

N/A
Recruiting
Led By Momchilo Vuyisich
Research Sponsored by Viome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~4months
Awards & highlights

Study Summary

This trial is for US residents with either gastrointestinal, immuno-metabolic or mental wellness issues. They enroll by signing a form, complete a survey, and are randomized into one of three groups. The study is done entirely by the participants, with no clinical sites involved.

Who is the study for?
This trial is for US residents aged 25-75 with gastrointestinal issues, specifically IBS as per ROME IV criteria and an IBS-SSS score of 125-450. Participants must understand English and be willing to follow the study's instructions after signing a consent form. Those with unexplained weight loss, fevers, anemia, or blood in stool cannot join.Check my eligibility
What is being tested?
The Viome Nutritional Programs are being tested to see if they improve gastrointestinal health. Participants will complete a survey and then be randomly placed into one of three groups without visiting clinical sites. They'll either receive the VIOME Precision Nutrition Program or condition-based supplements designed by VIOME.See study design
What are the potential side effects?
Potential side effects are not specified but may include changes in digestion or allergic reactions to supplements. As this is a nutritional program, side effects might be less severe than pharmaceutical interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~4months
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~4months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of VIOME Precision Nutrition Program (VPNP)
Efficacy of VIOME's designed condition based supplements (VCS)

Trial Design

3Treatment groups
Active Control
Group I: Viome's condition-based supplementsActive Control1 Intervention
Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.
Group II: PlaceboActive Control1 Intervention
Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Group III: Viome's Precision Nutrition ProgramActive Control1 Intervention
Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Find a Location

Who is running the clinical trial?

ViomeLead Sponsor
20 Previous Clinical Trials
37,387 Total Patients Enrolled
Momchilo VuyisichPrincipal InvestigatorViome
11 Previous Clinical Trials
2,612 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Viome Life Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
2022. "Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465629.
~44 spots leftby Dec 2024
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