Primary Objective: • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia Secondary Objective: • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of: 1. Lactobacillus acidophilus NAS, 30 billion CFU 2. Bifidobacterium bifidum Malyoth, 120 billion CFU 3. Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU
2 capsules, 3x/day placebo capsules
In-Quest Medical Research, LLC
Duluth, Georgia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Abdominal pain severity
Time frame: 8 weeks
Stool consistency (Bristol Stool Chart)
Time frame: 8 weeks
Dyspepsia Symptom Severity Index (DSSI)
Time frame: 8 weeks
Proportion of subjects with 1 or more adverse events
Time frame: 8 weeks
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