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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905524
• Other study ID #: V216
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 23, 2022

Study information

• Verified date: March 2022
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• VIOME Precision Nutrition Program
Diet and supplements recommendations

Locations

Country	Name	City	State
United States	Viome Research Institute	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	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
Primary	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
Primary	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