Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Study Overview
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Brief Summary
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The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.

Detailed Description
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Background & Significance: The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. Research Design & Methods: This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.

Official Title
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Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: Probiotic Dietary Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age 21-75 years Exclusion Criteria: Currently taking a probiotic, prebiotic, or fiber supplement (or they were taken within 10 days prior to screening) Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within 28 days prior to screening) Currently taking any supplements or medications impacting gastrointestinal motility Active gastrointestinal infection Current or previous history of chronic bowel disease Current or previous history of liver disease Current or previous history of chronic kidney disease History of gastrointestinal surgery A major medical or surgical event requiring hospitalization within 3 months prior to screening Current or previous history of cardiovascular disease Current or previous history of pre-Diabetes, diabetes mellitus, or hypoglycemia Known infection with human immunodeficiency virus, tuberculosis, hepatitis B or hepatitis C Genitourinary bacterial infections within 28 days prior to screening Current or previous history of seizure disorder Current or previous history of psychiatric illness History of alcoholism Cancer within the last 5 years Smoking or use of nicotine containing products within 28 days prior to screening Use of drugs of abuse and recreational drugs/substances within 12 months prior to screening Known intolerance or allergy to ingredients in the study supplement Women who are lactating, pregnant or planning pregnancy within the next two months Currently participating in another interventional research study or participated in another interventional study within 28 days prior to screening

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Dietary Supplement<br>Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days | Dietary Supplement: Probiotic Dietary Supplement<br>* Dietary supplement containing a combination of 8 probiotic strains<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of participants who withdraw from the study due to adverse events during the supplementation period | Tolerability of oral intake of the probiotic supplement will primarily be evaluated by determining the frequency of participants who withdraw from the study due to adverse events during the supplementation period | 0-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White blood cell count | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Red blood cell count | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Hemoglobin | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Hematocrit | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Mean corpuscular volume | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Mean corpuscular hemoglobin | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Mean corpuscular hemoglobin conc. | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Red cell distribution width | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Platelet count | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Mean platelet volume | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Absolute Neutrophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Absolute Lymphocytes | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Absolute Monocytes | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Absolute Eosinophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Absolute Basophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Neutrophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Lymphocytes | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Monocytes | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Eosinophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Basophils | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Albumin | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Globulin | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Albumin/Globulin Ratio | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Alkaline Phosphatase | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Alanine Transaminase | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Aspartate Aminotransferase | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Blood urea nitrogen (BUN) | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Creatinine | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| BUN/Creatinine ratio | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Calcium | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Carbon Dioxide | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Chloride | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Estimated Glomerular Filtration Rate | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Potassium | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Sodium | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Bilirubin | Frequency of adverse change before and after the supplementation period | 0-10 days | 
| Total Protein | Frequency of adverse change before and after the supplementation period | 0-10 days |