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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
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| Dietary Supplement with actives | Active Comparator | Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Dietary Supplement with actives |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | from enrollment to end of study at 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment to end of study at 10 weeks |
| Changes in Gut Microbiome Composition (Stool Samples) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Daily Quality of Life (DQLQ) Scores | 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. | from enrollment to end of study at 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Consumer Research | St. Petersburg | Florida | 33702 | United States |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement |
Dietary Supplement containing probiotic and prebiotic ingredients |
|
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. |
| from enrollment to end of study at 10 weeks |
| Changes in Daily Diet and Symptoms (Daily Diary) |
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. |
| from enrollment to end of study at 10 weeks |
| Changes During Initial Dose Effects (24-Hour Questionnaire) | 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. | from enrollment to end of study at 10 weeks |