Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
ConditionGastrointestinal Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorViome
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
VIOME Precision Nutrition Program
Combination productPrecision 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 supplements
Dietary supplementPre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: PlaceboNo intervention 0 interventions
Group B: Viome's Precision Nutrition ProgramActive comparator 1 intervention
Group C: Viome's condition-based supplementsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of VIOME's designed condition based supplements (VCS)
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Time frame
~4 months2
Efficacy of VIOME Precision Nutrition Program (VPNP)
Number of participants that show an improvement in GI health compared to baseline survey assessment.
Time frame
~4months Source ClinicalTrials.gov