Recruiting

Viome Nutritional ProgramsViome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Sponsor:

Viome

Code:

NCT05465629

Conditions

Gastrointestinal Health

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

VIOME Precision Nutrition Program

VIOME-designed condition-based supplements

Study Details

Brief 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.

Conditions

Gastrointestinal Health

Study ID

NCT05465629

Start date

Nov 18, 2022

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Placebo

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.

active comparator: Viome's Precision Nutrition Program

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.

active comparator: Viome's condition-based supplements

Interventions

VIOME 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.

VIOME-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.

Primary outcome measure

Efficacy of VIOME's designed condition based supplements (VCS) [ Time Frame: ~4 months ]
Efficacy of VIOME Precision Nutrition Program (VPNP) [ Time Frame: ~4months ]

Central Contacts and Locations

Central contacts

Mory Mehrtash

(425) 300-6933 studies@viome.com

Momchilo Vuyisich

(425) 300-6933 studies@viome.com

Locations

Viome Life Sciences

Recruiting

Bothell, Washington, United States, 98011

Contacts

Momchilo Vuyisich, PhD

(425) 300-6933 studies@viome.com

Mory Mehrtash, MSHS

(425) 300-6933 studies@viome.com

Principal Investigator:

Momchilo Vuyisich, PhD

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

Nausea
Vomiting
Diarrhea
Constipation
Bloating
Gastroesophageal
Viome
Nutrition
Supplements
VPNP
Viome precision nutrition program
Reflux
Diet
Microbiome
Biome
Gastrointestinal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.