Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

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

NCT05465629

V211.1

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:

Treatment:

Dietary Supplement: VIOME-designed condition-based supplements