NCT05465629 Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
| NCT ID | NCT05465629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Viome |
| Condition | Gastrointestinal Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-11-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2022-11-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Momchilo Vuyisich
PRINCIPAL INVESTIGATOR
Viome
Frequently Asked Questions
Who can join the NCT05465629 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Gastrointestinal Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05465629 currently recruiting?
Yes, NCT05465629 is actively recruiting participants. Contact the research team at studies@viome.com for enrollment information.
Where is the NCT05465629 trial being conducted?
This trial is being conducted at Bothell, United States.
Who is sponsoring the NCT05465629 clinical trial?
NCT05465629 is sponsored by Viome. The principal investigator is Momchilo Vuyisich at Viome. The trial plans to enroll 150 participants.