Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
NCT05465629

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

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Viome Life Sciences

Bothell, Washington, United States, 98011

Actively Recruiting

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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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Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions | DecenTrialz