Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Gastrointestinal Health
In brief
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.
Key facts
- Study ID
- NCT05465629
- Run by
- Viome
- People needed
- 150
- Starts
- 2022-11-18
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Viome Life Sciences — Bothell, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.