Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

Gastrointestinal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465629
• Other study ID #: V211.1
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Viome
• Contact: Mory Mehrtash
• Phone: (425) 300-6933
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Health

Intervention

Combination Product:
• 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.

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of VIOME's designed condition based supplements (VCS)	Number of participants that show an improvement in GI health compared to baseline survey assessment.	~4 months
Primary	Efficacy of VIOME Precision Nutrition Program (VPNP)	Number of participants that show an improvement in GI health compared to baseline survey assessment.	~4months