Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
34
Placebo
Dietary Supplement containing probiotic and prebiotic ingredients
Princeton Consumer Research
St. Petersburg, Florida, United States
Changes in Gastrointestinal Symptoms (GSRS) Scores
Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms. Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects.
Time frame: from enrollment to end of study at 10 weeks
Changes in Stool Consistency (Bristol Stool Chart)
Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.
Time frame: from enrollment to end of study at 10 weeks
Changes in Immune Biomarkers (Blood Samples) Levels
Blood sample analysis will focus on immune function biomarkers counts. Changes in immune biomarkers will be compared between baseline, active treatment, and placebo periods.
Time frame: from enrollment to end of study at 10 weeks
Changes in Gut Microbiome Composition (Stool Samples)
Stool samples will be analyzed for changes in microbial diversity and specific bacterial populations, which may indicate changes in gut health. Comparisons will be made between active treatment and placebo periods to identify any significant shifts in the microbiome.
Time frame: from enrollment to end of study at 10 weeks
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