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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04905524
Enrollment
10000
Registered
2021-05-27
Start date
2020-09-01
Completion date
2022-03-23
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

Diet and supplements recommendations

Sponsors

Viome
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Disease activity changes for IBS~5 monthsChange 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~5 monthsChange 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~5 monthsChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026