Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Last updated: January 27, 2025
Sponsor: Viome
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

VIOME Precision Nutrition Program

VIOME-designed condition-based supplements

Clinical Study ID

NCT05465629
V211.1
  • Ages 25-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • 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 criteria

  • 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:

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

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: VIOME Precision Nutrition Program
Phase:
Study Start date:
November 18, 2022
Estimated Completion Date:
December 31, 2026

Study Description

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.

Connect with a study center

  • Viome Life Sciences

    Bothell, Washington 98011
    United States

    Active - Recruiting

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