Recruitment and selection of participants
illness, fever, major bowel resection, ulcerative colitis, hypertension5, cancer, gastritis, Crohn’s disease, Diabetes, metabolic syndrome, squamous or basal cell carcinomas of the skin, IBD, gastrointestinal disorders, colitis
INFLAMMATORY BOWEL DISEASE, IRRITABLE BOWEL SYNDROME (IBS), INFECTIOUS GASTROENTERITIS, TYPE II DIABETES, CANCER, RECRUITMENT, TYPE 2 DIABETES, DISEASES, TYPE I DIABETES, POSITIVE, ULCERATIVE COLITIS, HIV INFECTION, GASTRITIS, ELEVATED TRIGLYCERIDES, COLITIS, CHRONIC DIARRHEA, INDETERMINATE COLITIS, ACUTE DISEASE, DIABETES, METABOLIC SYNDROME, HYPERTENSION, IMMUNODEFICIENCY, GASTROINTESTINAL DISORDERS
Participant recruitment was conducted in the local community via online advertisement and radio in different community groups, as well as e-mails to past research participants that consented to being contacted for future research. The current study assessed 606 participants for eligibility. They completed an online screening questionnaire and a clinic visit between September 2017 and June 2018. The primary inclusion criteria included the following: age ≥ 18 years.At least two of the five criteria used to diagnose metabolic syndrome as defined by either the ATP-III Guideline, or by the International Diabetes Federation Guideline:1. Increased waist circumference, with ethnic-specific waist circumference cut-points:White and all other ethnic groups – men ≥ 94cm; women ≥ 80 cmSouth Asians, Chinese, and Japanese – men ≥ 90cm; women ≥ 80 cm2. Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides3. 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 HDL4. Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension5. 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 requiredOtherwise, healthy subjects willing and able to provide blood and stool specimens, able to provide signed and dated informed consent, and be willing to follow protocol.Exclusion criteria included the following:· Body mass index ≥ 40· Vital signs outside of acceptable range at screening visit, i.e., blood pressure >159/99, oral temperature ≥100°F, pulse >100, LDL >190 mg/dL.· 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; large doses of commercial probiotics consumed (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.· Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever. Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history, including Type I diabetes. (Type II diabetes ok if controlled by metformin or diet).· History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision (allowed if cancer was several years past and not requiring in continual care).· Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet. Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.· Positive test for HIV, HBV or HCV.· Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.· Major surgery of the GI tract, with the exception of appendectomy, in the past five years.· Any major bowel resection at any time. History of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn’s disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (IBS) (moderate-severe); persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, · Female who is pregnant or lactating.· History of gallbladder removalAll study participants provided written informed consent. The study was approved annually by the Stanford University Human Subjects Committee. Trial was registered at ClinicalTrials.gov, identifier: NCT03201068.