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OpenTrials
Completed

NCT Number: NCT04905524

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

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Colonic Diseases Colonic Diseases, Functional Depression Digestive System Diseases Gastrointestinal Diseases IBS - Irritable Bowel Syndrome Intestinal Diseases Irritable Bowel Syndrome Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viome Research Institute

Bothell, Washington, 98011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIOME Precision Nutrition Program

Dietary Supplement

Diet and supplements recommendations

Other names: VPNP

Primary outcomes

  1. Disease activity changes for IBS

    Time frame: ~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.

  2. Disease activity changes depression

    Time frame: ~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.

  3. Disease activity changes anxiety

    Time frame: ~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.

Sponsors and collaborators

Lead sponsor

Viome

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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