Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome

Study start date: September 14, 2017

Inclusion Criteria: * 18 and older * Must have metabolic syndrome as defined by having at least 2 of the 5 criteria per either ATP III guidelines OR International Diabetes Federation (IDF) guidelines: ATP III guidelines: 1. Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in) 2. Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides 3. Serum high-density lipoprotein (HDL) cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol 4. Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure 5. Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose International Diabetes Federation Guidelines: 1. Increased waist circumference, with ethnic-specific waist circumference cut-points: White and all other ethnic groups - Men ≥ 94 cm; Women ≥ 80 cm South Asians, Chinese, and Japanese - Men ≥ 90 cm; Women ≥ 80 cm PLUS any two of the following: 2. Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides 3. HDL cholesterol \<40 mg/dL (1.03 mmol/L) in men or \<50 mg/dL (1.29 mmol/L) in women, or treatment for low HDL 4. Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension 5. FPG ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type 2 diabetes; an oral glucose tolerance test is recommended for patients with an elevated fasting plasma glucose, but not required. Exclusion Criteria: * Body Mass Index (BMI) ≥ 40 * LDL \>160 mg/dL. * Vital signs outside of acceptable range at Screening Visit: blood pressure \>159/99, oral temperature ≥ 100°F, pulse \>100. * Use of any of the following drugs within the last 6 months:systemic antibiotics (must be discontinued and avoided for 2 months prior to the study start), antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents; * Use of large doses of commercial probiotics consumed within the last 6 months (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (must be discontinued and avoided for one month prior to the study start). Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.