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.
This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)
Daily placebo for 10 weeks
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Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score
Time frame: 10 weeks
Gastrointestinal Symptom Rating Scale subscores
Time frame: 10 weeks
Gas severity
Time frame: 10 weeks
Bloating severity
Time frame: 10 weeks
Acid indigestion severity
Time frame: 10 weeks
Abdominal cramping severity
Time frame: 10 weeks
Stool consistency (measured with Bristol Stool Form Scale)
Time frame: 10 weeks
Stool frequency
Time frame: 10 weeks
Concomitant medication use
Time frame: 10 weeks
Adverse event frequency
Time frame: 10 weeks
Adverse event severity
Time frame: 10 weeks
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Clinical Research Associates of Tidewater
Norfolk, Virginia, United States