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

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome; Depression, Anxiety
• Interventions: Dietary Supplement: VIOME Precision Nutrition Program

• Registration Number: NCT04905524
• Lead Sponsor: Viome

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.

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Status Verified: 2022-03
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	VIOME Precision Nutrition Program	All participants received the intervention in this trial (VPNP diet and supplement recommendations).

Primary Outcome Measures

Name	Time	Method
Disease activity changes anxiety	~5 months	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.
Disease activity changes depression	~5 months	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.
Disease activity changes for IBS	~5 months	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.

Trial Locations

Locations (1)

Viome Research Institute; 🇺🇸 Bothell, Washington, United States