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

NCT04905524 | Completed

• 1 other identifier: V216
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety; IBS - Irritable Bowel Syndrome

Keywords

Depression; Anxiety; Irritable bowel syndrome; Viome precision nutrition program; VNPN; IBS; PHQ9; GAD7; ROME-IV; Viome; Diet; Nutrition; Supplements

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Intervention arm

OTHER

All participants received the intervention in this trial (VPNP diet and supplement recommendations).

Dietary Supplement: VIOME Precision Nutrition Program

Interventions

VIOME Precision Nutrition Program DIETARY_SUPPLEMENT

Diet and supplements recommendations

Also known as: VPNP

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable/unwilling to complete the provided questionnaires

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Research Institute

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Momo Vuyisich, PhD

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: This is a single group cohort study; the first cohort consists of participants with self reported Irritable Bowel Syndrome (IBS), the second cohort consists of participants with self reported depression and the last cohort consists of participants with self reported anxiety. All cohorts receive diet and supplement recommendations from Viome based on participants' sample results.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 27, 2021
• Study Start: September 1, 2020
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)