Viome Nutritional Programs for Gastrointestinal Health

This study is looking at how well two different Viome nutritional programs work for people with gastrointestinal (gut) health issues. You might receive the VIOME Precision Nutrition Program, which offers personalized supplements, diet advice, and coaching based on your unique microbiome (the collection of tiny living things in your gut). Or, you might receive VIOME-designed condition-based supplements, which are pre-made supplements for general health conditions, also with possible diet advice and coaching. The study aims to see how effective these programs are after about four months. You can join if you are a US resident between 25 and 75 years old, can speak and read English, and don't have certain unexplained health problems like weight loss or anemia. The study is currently unclear on its recruitment status, but plans to enroll 150 participants.

Study design
This is an interventional study that plans to enroll 150 participants. You will be randomly assigned to one of three groups: a control group, the VIOME-designed condition-based supplements group, or the VIOME Precision Nutrition Program group.
What's involved
You will complete a survey at the beginning of the study. The study will last approximately 4 months for each participant.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at approximately 4 months, which is the duration of participation.

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NCT05465629

Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Recruiting
NAAges 25–75InterventionalTreatment
Viome
~150 participants
Updated 2025-01-29 on ClinicalTrials.gov
What's tested:VIOME Precision Nutrition ProgramVIOME-designed condition-based supplements

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of VIOME's designed condition based supplements (VCS)
Measured over ~4 months
+1 more outcome measured
Gastrointestinal Health
1 sites across 1 states
Washington1
  • Momchilo Vuyisich · PRINCIPAL_INVESTIGATOR · Viome

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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.
Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (inclusive)

Exclusion

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
\< 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:
GI surgery except:
  • Efficacy of VIOME's designed condition based supplements (VCS)~4 months

    Number of participants that show an improvement in GI health compared to baseline survey assessment.

  • Efficacy of VIOME Precision Nutrition Program (VPNP)~4months

    Number of participants that show an improvement in GI health compared to baseline survey assessment.