Healthy Adults
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTProbiotic Dietary Supplement
Dietary supplement containing a combination of 8 probiotic strains
Sponsors
National University of Natural Medicine
Metagenics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of participants who withdraw from the study due to adverse events during the supplementation period | 0-10 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cell count | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Hemoglobin | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Hematocrit | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Mean corpuscular volume | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Mean corpuscular hemoglobin | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Mean corpuscular hemoglobin conc. | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Red cell distribution width | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Platelet count | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Mean platelet volume | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Absolute Neutrophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Absolute Lymphocytes | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Absolute Monocytes | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Absolute Eosinophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Absolute Basophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Neutrophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Lymphocytes | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Monocytes | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Eosinophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
| White blood cell count | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Albumin | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Globulin | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Albumin/Globulin Ratio | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Alkaline Phosphatase | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Alanine Transaminase | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Aspartate Aminotransferase | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Blood urea nitrogen (BUN) | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Creatinine | 0-10 days | Frequency of adverse change before and after the supplementation period |
| BUN/Creatinine ratio | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Calcium | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Carbon Dioxide | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Chloride | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Estimated Glomerular Filtration Rate | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Potassium | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Sodium | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Bilirubin | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Total Protein | 0-10 days | Frequency of adverse change before and after the supplementation period |
| Basophils | 0-10 days | Frequency of adverse change before and after the supplementation period |
Countries
United States
Outcome results
None listed