Gastrointestinal HealthNCT05465629
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
A study testing VIOME Precision Nutrition Program and VIOME-designed condition-based supplements in people with Gastrointestinal Health, run by Viome at 1 site in United States.
Trial summary
US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Gastrointestinal Health
- What is being tested?
- VIOME Precision Nutrition Program and VIOME-designed condition-based supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of the United States
- Females and males ages 25-75 (inclusive)
- Able to speak and read English
- No unexplained weight loss, fevers, anemia, or blood in stool
- Willing and able to follow the trial instructions, as described in the recruitment letter
- Signed and dated informed consent prior to any trial-specific procedures.
- Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (inclusive)
Who cannot join
- Unwilling to change current diet
- Prior use of Viome products or services
- Antibiotic use in the previous 4 weeks
- Women who are pregnant (current or planned in the next 4 months), or breastfeeding
- < 90 days postpartum
- Active infection
Show all 20Show fewer
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Significant diet or lifestyle changes in the previous 1 month
- IBD diagnosis
- Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
- Cancer therapy within the previous 1 year
- Major surgery in the last 6 months or planned in the next 4 months
- Prescribed any drug(s) that may interact with the supplement formulations
- Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements
- Allergies to any study-specific supplement ingredients
- Currently on a specific diet:
- FODMAP KETO PALEO
- Gastrointestinal disease including: Esophagitis Celiac disease GI malignancy or obstruction Peptic ulcer Duodenal or gastric ulcer disease
- GI surgery except:
- Appendectomy and benign polypectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Viome Life Sciences
Bothell, Washington, 98011
Momchilo Vuyisich, PhD, (425) 300-6933, studies@viome.com
Mory Mehrtash, MSHS, (425) 300-6933, studies@viome.com
About this study
Official title: Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions
US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.
Read the detailed description
Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.
Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.
- Conditions
- Gastrointestinal Health
- Being tested
- VIOME Precision Nutrition Program, VIOME-designed condition-based supplements
- Keywords
- Nausea, Vomiting, Diarrhea, Constipation, Bloating, Gastroesophageal, Viome, Nutrition, Supplements, VPNP, Viome precision nutrition program, Reflux, Diet, Microbiome, Biome, Gastrointestinal
- Medical subject headings
- Nausea, Vomiting, Diarrhea, Constipation, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOME Precision Nutrition ProgramCombination product
Also called VPNP
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
VIOME-designed condition-based supplementsDietary supplement
Also called VCS
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. |
| Viome's Precision Nutrition Program | Active comparator | Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. Receives: Combination Product: VIOME Precision Nutrition Program |
| Viome's condition-based supplements | Active comparator | Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. Receives: Dietary Supplement: VIOME-designed condition-based supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of VIOME's designed condition based supplements (VCS)
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Measured: ~4 months
Efficacy of VIOME Precision Nutrition Program (VPNP)
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Measured: ~4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start18 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465629
- Sponsor's protocol ID
- V211.1
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions
- ClinicalTrials.gov ID
- NCT05465629
- Acronym / sponsor ID
- V211.1
- Conditions
- Gastrointestinal Health
- Keywords
- Nausea, Vomiting, Diarrhea, Constipation, Bloating, Gastroesophageal, Viome, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (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.
US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.
Detailed description
Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.
Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Participants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. |
| Viome's Precision Nutrition Program | Active comparator | Combination Product: VIOME Precision Nutrition ProgramParticipants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. |
| Viome's condition-based supplements | Active comparator | Dietary Supplement: VIOME-designed condition-based supplementsParticipants who have gastrointestinal issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Resident of the United States
- Females and males ages 25-75 (inclusive)
- Able to speak and read English
- No unexplained weight loss, fevers, anemia, or blood in stool
- Willing and able to follow the trial instructions, as described in the recruitment letter
Key exclusion criteria (20 listed)
- Unwilling to change current diet
- Prior use of Viome products or services
- Antibiotic use in the previous 4 weeks
- Women who are pregnant (current or planned in the next 4 months), or breastfeeding
- < 90 days postpartum
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: VPNPPrecision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. | Combination product | Viome's Precision Nutrition Program |
| VIOME-designed condition-based supplementsAlso: VCSPre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. | Dietary supplement | Viome's condition-based supplements |
Primary outcome
Efficacy of VIOME's designed condition based supplements (VCS)
Time frame: ~4 months
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Efficacy of VIOME Precision Nutrition Program (VPNP)
Time frame: ~4months
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Momchilo Vuyisich 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 and VIOME-designed condition-based supplements in people with Gastrointestinal Health, 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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mory Mehrtash ((425) 300-6933, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of VIOME's designed condition based supplements (VCS) (time frame: ~4 months). The study lists 2 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 29 Jan 2025.