Prospective Tolerability Assessment of a Probiotic Dietary Supplement

Prospective Tolerability Assessment of a Probiotic Dietary Supplement

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.

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