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| Name | Class |
|---|---|
| National University of Natural Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Dietary Supplement | Experimental | Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Dietary Supplement | Dietary Supplement | Dietary supplement containing a combination of 8 probiotic strains |
|
| 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 |
| 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 |
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Inclusion Criteria:
- Age 21-75 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noelle Patno, PhD | Metagenics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personalized Lifestyle Medicine Center | Gig Harbor | Washington | 98332 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34393673 | Result | Ryan JJ, Patno NM. Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults. Integr Med (Encinitas). 2021 Feb;20(1):24-34. |
| Label | URL |
|---|---|
| Full Text | View source |
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Single Group Assignment
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| 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 |