Back to resultsActivity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
Primary Purpose
Depression, Anxiety, IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIOME Precision Nutrition Program
Sponsored by
About this trial
This is an interventional supportive care trial for Depression, Anxiety focused on measuring Depression, Anxiety, Irritable bowel syndrome, Viome precision nutrition program, VNPN, IBS, PHQ9, GAD7, ROME-IV, Viome, Diet, Nutrition, Supplements
Eligibility Criteria
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
Sites / Locations
- Viome Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention arm
Arm Description
All participants received the intervention in this trial (VPNP diet and supplement recommendations).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905524
Brief Title
Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
Official Title
Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Viome
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Other
Arm Description
All participants received the intervention in this trial (VPNP diet and supplement recommendations).
Intervention Type
Dietary Supplement
Intervention Name(s)
VIOME Precision Nutrition Program
Other Intervention Name(s)
VPNP
Intervention Description
Diet and supplements recommendations
Primary Outcome Measure Information:
Title
Disease activity changes for IBS
Description
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.
Time Frame
~5 months
Title
Disease activity changes depression
Description
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.
Time Frame
~5 months
Title
Disease activity changes anxiety
Description
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.
Time Frame
~5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momo Vuyisich, PhD
Organizational Affiliation
Viome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viome Research Institute
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
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