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RecruitingNot ApplicableNCT05465629

Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions

Sponsor

Viome

Enrollment

150 participants

Start Date

Nov 18, 2022

Study Type

INTERVENTIONAL

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

Min Age: 25 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria20

  • 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

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Interventions

COMBINATION_PRODUCTVIOME Precision Nutrition Program

Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

DIETARY_SUPPLEMENTVIOME-designed condition-based supplements

Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

Locations(1)

Viome Life Sciences

Bothell, Washington, United States

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NCT05465629