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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Anxiety, IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: VIOME Precision Nutrition Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention arm<br>All participants received the intervention in this trial (VPNP diet and supplement recommendations). | Dietary Supplement: VIOME Precision Nutrition Program<br>* Diet and supplements recommendations<br>* Other names: VPNP;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Irritable bowel syndrome, Viome precision nutrition program, VNPN, IBS, PHQ9, GAD7, ROME-IV, Viome, Diet, Nutrition, Supplements