Princeton Consumer Research
St. Petersburg, Florida, 33702, United States
NCT Number: NCT06794619
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
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
St. Petersburg, Florida, 33702, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo
Dietary Supplement containing probiotic and prebiotic ingredients
Time frame: from enrollment to end of study at 10 weeks
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
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
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
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
DQLQ scores will be compared across different phases to assess any impacts of the supplement on participants' well-being and daily functioning.
Changes in quality of life will be analyzed at baseline, end of each treatment period, and post-washout.
Time frame: from enrollment to end of study at 10 weeks
Changes in daily food intake, symptom levels, and stool consistency from the diaries will be analyzed to identify any patterns or correlations between dietary habits and digestive health outcomes. This data will provide exploratory insights into lifestyle factors that may influence supplement effects.
Time frame: from enrollment to end of study at 10 weeks
Short-Term Effects on Symptoms (24-Hour Data). The 24-hour questionnaire data following the initial dose will be used to capture any immediate digestive effects of the supplement.
Changes in reported symptoms within this initial period will be compared between the active supplement and placebo groups.
Olly, PBC
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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