Nutritional programs to improve gastrointestinal health
Official title: Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions
Run by Viome · NCT05465629 · Data updated 2026-11-12
This study is testing whether a special diet and supplements can help people with gastrointestinal issues feel better over four months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Viome Industry-sponsored |
| Locations | 1 site (Bothell, Washington) |
| Status | Recruiting |
| Started | November 18, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT05465629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 25-75 diagnosed with IBS according to ROME IV criteria and experiencing specific gastrointestinal symptoms.
✕Probably not a fit
Patients with conditions such as IBD, significant recent lifestyle changes, or those unwilling to modify their diet may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves US residents with gastrointestinal issues who will be screened and enrolled after signing informed consent. Participants will complete a survey and be randomized into one of three groups: a control group, a group receiving Viome's condition-based supplements, or a group following the Viome Precision Nutrition Program. The interventions aim to provide dietary recommendations and supplements to alleviate symptoms associated with gastrointestinal wellness over a period of approximately four months.
Why it matters
Potential benefit: If successful, this study could lead to improved management of gastrointestinal conditions through personalized nutrition and supplementation.
How similar studies have gone: While there is ongoing interest in personalized nutrition for gastrointestinal health, this specific approach using Viome's programs is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 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) Exclusion criteria * 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 * 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
Where it's running
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Viome Life Sciences
Bothell, Washington, United States Recruiting
Study contacts
- Principal investigator: Momchilo Vuyisich — Viome
- Study coordinator: Mory Mehrtash
- Email: studies@viome.com
- Phone: (425) 300-6933
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.