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Trenev Trio®/Healthy Trinity® for Gastrointestinal Symptoms
Phase 2 & 3
Waitlist Available
Led By Duane Wombolt, MD
Research Sponsored by Sprim Advanced Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.
Eligible Conditions
- Gastrointestinal Symptoms
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gastrointestinal Quality of Life Index (GIQLI) total score
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
Secondary outcome measures
Abdominal cramping severity
Acid indigestion severity
Adverse event frequency
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Trenev Trio®/Healthy Trinity®Experimental Treatment1 Intervention
80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks
Group II: Placebo capsulePlacebo Group1 Intervention
40 subjects allocated to daily placebo capsule for 10 weeks
Find a Location
Who is running the clinical trial?
Sprim Advanced Life SciencesLead Sponsor
34 Previous Clinical Trials
5,489 Total Patients Enrolled
1 Trials studying Gastrointestinal Symptoms
100 Patients Enrolled for Gastrointestinal Symptoms
The National Institute of ProbioticsOTHER
1 Previous Clinical Trials
22 Total Patients Enrolled
Duane Wombolt, MDPrincipal InvestigatorClinical Research Associates of Tidewater
1 Previous Clinical Trials
120 Total Patients Enrolled
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