Depression, AnxietyNCT04905524
Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
A study testing VIOME Precision Nutrition Program in people with Depression, Anxiety and IBS - Irritable Bowel Syndrome, run by Viome at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, IBS - Irritable Bowel Syndrome
- What is being tested?
- VIOME Precision Nutrition Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable/unwilling to complete the provided questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- VIOME Precision Nutrition Program
- Keywords
- Depression, Anxiety, Irritable bowel syndrome, Viome precision nutrition program, VNPN, IBS, PHQ9, GAD7, ROME-IV, Viome, Diet, Nutrition, Supplements
- Medical subject headings
- Depression, Anxiety Disorders, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOME Precision Nutrition ProgramDietary supplement
Also called VPNP
Diet and supplements recommendations
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | All participants received the intervention in this trial (VPNP diet and supplement recommendations). Receives: Dietary Supplement: VIOME Precision Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~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.
Measured: ~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.
Measured: ~5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Sep 2020
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Momchilo Vuyisich, Viome
- Investigators
- Momo Vuyisich, PhD, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905524
- Sponsor's protocol ID
- V216
- Status last verified
- Mar 2022
- First submitted
- 19 May 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
- ClinicalTrials.gov ID
- NCT04905524
- Acronym / sponsor ID
- V216
- Keywords
- Depression, Anxiety, Irritable bowel syndrome, Viome precision nutrition program, VNPN, IBS, PHQ9, GAD7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Dietary Supplement: VIOME Precision Nutrition ProgramAll participants received the intervention in this trial (VPNP diet and supplement recommendations). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Unable/unwilling to complete the provided questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIOME Precision Nutrition ProgramAlso: VPNPDiet and supplements recommendations | Dietary supplement | Intervention arm |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momo Vuyisich, PhD principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIOME Precision Nutrition Program in people with Depression, Anxiety and IBS - Irritable Bowel Syndrome, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity changes for IBS (time frame: ~5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.