Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)

Viome costumers are consented and recruited for this study and complete the questionnaires upon enrollment. Any participant who previously self reported depression, anxiety, or Irritable Bowel Syndrome (IBS) qualify for this study.

All participants receive Viome's diet, supplement and recommendations.

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety; IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: VIOME Precision Nutrition Program

Detailed Description

Participants receive Viome Precision Nutrition Program (VPNP) after completing the health assessment and questionnaire. VPNP consists of diet, supplement and recommendations based on results from their sample results and their self reported questionnaire.

After approximately 5 months, participants were given the same health assessment questionnaire.

The results and data collected before and after the VPNP are analyzed to find correlations and differences between the measurements taken at the beginning of the trial and again approximately 5 months after.

• Study Type: Interventional
• Enrollment (Actual): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Viome Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PHQ-9 score 5 or above
• GAD-7 score 5 or above
• IBS ROME-IV score 125 or above
• Females and males aged 18 years or older
• Signed and dated informed consent prior to any trial-specific procedures are performed
• Able to speak and read English
• Willing and able to follow the trial instructions
• Viome existing costumer

Exclusion Criteria:

• Unable/unwilling to complete the provided questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention arm; All participants received the intervention in this trial (VPNP diet and supplement recommendations).	Dietary supplement: VIOME Precision Nutrition Program; Diet and supplements recommendations; Other Names: VPNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity changes for IBS	Change of disease activity measurements in participants with self reported IBS after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For IBS, Rome IV classification and criteria based on interpretation and self reporting of IBS, experience and symptoms were used to measure before and after VPNP for approximate duration of 5 months.	~5 months
Disease activity changes depression	Change of disease activity measurements in participants with self reported depression after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For depression, brief patient health questionnaire mood scale (PHQ-9) was used.	~5 months
Disease activity changes anxiety	Change of disease activity measurements in participants with self reported anxiety after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For anxiety, General Anxiety Disorder 7 (GAD-7) was used, which is designed to assess the participants' health status during the previous 2 weeks.	~5 months

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momo Vuyisich, PhD, Viome

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Depression; IBS; Anxiety; Nutrition; Diet; PHQ9; Irritable bowel syndrome; Supplements; GAD7; Viome precision nutrition program; VNPN; ROME-IV; Viome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Pathologic Processes; Mood Disorders; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Depression; Depressive Disorder; Syndrome; Irritable Bowel Syndrome; Anxiety Disorders
• Other Study ID Numbers: V216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No