To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.
This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.
Study Type
OBSERVATIONAL
Enrollment
34
Synbiotic dietary supplement in capsule form
Kassandra Spates-Harden
Cleveland, Ohio, United States
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score
Time frame: Baseline, Day 28, day 49, day 77
Change in microbiome stool diversity
Time frame: Baseline, Day 28, day 49, day 77
Change in metabolome stool profile
Time frame: Baseline, Day 28, day 49, day 77
Change in metabolome urine profile
Time frame: Baseline, Day 28, day 49, day 77
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