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Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

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Viome

Status

Enrolling

Conditions

Gastrointestinal Health

Treatments

Combination Product: VIOME Precision Nutrition Program
Dietary Supplement: VIOME-designed condition-based supplements

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 3 patient groups

Placebo
No Intervention group
Description:
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.
Viome's Precision Nutrition Program
Active Comparator group
Description:
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.
Treatment:
Combination Product: VIOME Precision Nutrition Program
Viome's condition-based supplements
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: VIOME-designed condition-based supplements

Trial contacts and locations

1

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Central trial contact

Momchilo Vuyisich; Mory Mehrtash

Data sourced from clinicaltrials.gov

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