Eligibility Details:
- SUBJECT INCLUSION CRITERIA:
Healthy women and men will be eligible for study participation if they meet the following
criteria:
- A participant will have passed his/her 18th birthday and will not have attained the
age of 50 at the time of enrollment.
- Willing to allow storage of their biological samples.
- Able to comply with study procedures and swallow capsules.
SUBJECT EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from study
participation:
- Body Mass Index (BMI) greater than or equal to 35 or less than or equal to 18 kg/M(2).
- Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure
>160/100, oral temperature >100 degrees F, pulse >100.
- Use of any of the following drugs or devices within the last 6 months:
- systemic antibiotics, 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 10(8) cfu
or organisms per day), including tablets, capsules, lozenges, chewing gum, or
powders in which probiotic is a primary component. Ordinary dietary components
such as fermented beverages/milks, yogurts, and foods do not apply.
- anabolic steroids;
- intrauterine device, combination hormone vaginal ring for contraception (due to
unknown duration of local hormone effects), topical or systemic estrogens. Oral
contraceptives with a standard 28-day cycle will be permitted if the subject has
been consistently taking them for at least 1 month;
- oral, topical, intramuscular testosterone preparations.
- Illicit drug use, including amphetamines, cocaine, or heroin, within the last 6
months. Marijuana use is not exclusionary.
- Chronic smokers and subjects who use smokeless tobacco products (due to known effects
of tobacco on the oral microbiome).
- Claustrophobia.
- Use of antacids (proton pump inhibitors, sucralfate, H1 and H2 antagonists, and those
containing aluminum magnesium) within the last 3 months.
- Use of laxatives or enemas within the last 3 months.
- Diagnostic colonoscopy within the last 6 months.
- Use of topical antibiotics or topical steroids on the face, scalp, or neck, or on
arms, forearms, or hands within the previous 30 days.
- Use of vaginal/vulvar medications, including antifungals, within the previous 30 days.
Subjects may continue to use permitted vaginal contraceptives (spermicides and female
condoms) until 24 hours prior to sampling
- Use of isotretinoin within the past 5 years.
- Intranasal influenza vaccination within the last 6 months due to effects on mucosal
immunity.
- Acute disease at the time of enrollment (defer enrollment 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, dermatologic, endocrine, GI, hepatic, or renal
functional abnormality, as determined by medical history, physical examination, and/or
laboratory testing. Includes, but not limited to:
- A history of diabetes mellitus (Type 1 or 2), pituitary disease, hypothyroidism,
hyperthyroidism
- A history of physician-diagnosed asthma
- A history of allergy to any antibiotic medications, including amoxicillin
(penicillin) and/or azithromycin (macrolide)
- A history of food allergy requiring dietary accommodation
- Lactose-intolerance requiring dietary accommodation
- A history of a bleeding disorder
- Mononucleosis
- Liver disease, including non-alcoholic fatty liver disease, AST or ALT > 1.5
times normal value, cirrhosis
- Renal disease, as defined by serum creatinine concentrations > 1.5 mg/dL and/or
overt proteinuria
- Central nervous system disease, including previous history of cerebrovascular
accidents, dementia, and neurodegenerative disorders
- Clinically significant abnormal results on electrocardiogram (ECG) that in the
opinion of the PI, would place the patient at increased risk of QT-prolongation
or other cardiac event
- Genitourinary/Gynecologic conditions, including:
- Treatment for or suspicion of ever having had toxic shock syndrome
- History of hysterectomy or oophorectomy
- History of condyloma or human papillomavirus diagnosed within the previous 2
years
- History of candidiasis, urinary tract infection, or sexually transmitted disease
(specifically chlamydia, gonorrhea, syphilis, genital herpes, trichomoniasis)
diagnosed within the previous 6 months
- Evidence (by history or physical exam) of vulvar or vaginal irritation at
screening
- History of vulvar, vaginal, or cervical dysplasia within the previous 5 years
- History of cancer except for squamous or basal cell carcinomas of the skin that have
been medically managed by local excision.
- 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 excessive 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 at one sitting over the last 30 days.
- Positive test for HIV, hepatitis B virus, or hepatitis C virus indicating infection
(hepatitis B seropositivity conferred by vaccination is not exclusionary).
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency
(primary or acquired).
- Major surgery of the GI tract, including cholecystectomy or appendectomy, in the past
5 years. Any major bowel resection at any time.
- History of gastric stapling, lap band, or surgical procedure for treatment of obesity.
- History of GI disorders or diseases including:
- inflammatory bowel disease (IBD) including ulcerative colitis, Crohn s disease
(of any severity), or indeterminate colitis;
- irritable bowel syndrome (IBS);
- persistent, infectious gastroenteritis, colitis or gastritis, persistent or
chronic diarrhea of unknown etiology, Clostridium difficile infection
(recurrent), gastric or duodenal ulcer;
- Celiac disease;
- chronic constipation.
- Active behavioral or psychiatric conditions that would be incompatible with a safe and
successful participation in the study, including major depression, anxiety disorder,
schizophrenia, and presence of psychotic symptoms.
- Active eating disorders, including anorexia nervosa, bulimia, or binge eating
syndrome.
- Use of weight-loss drugs within the past 5 years.
- Weight change (intended or unintended; loss or gain) of more than 10% of total body
weight in the 3 months before admission.
- Regular urinary incontinence necessitating use of incontinence protection garments.
- Female who is pregnant, intending to become pregnant, or lactating.
- History of recurrent rashes within the past 6 months.
- At the time of the screening visit:
- multiple blisters, pustules, boils, abscesses, erosions or ulcers on the scalp,
face, neck, arms, forearms, or hands;
- uniformly thickened, cracking, dry skin on bilateral palms and/or soles;
- disseminated rash (at multiple body sites or extending throughout a broad body
area).
- Subjects who are unable to complete required study visits per allotted visit windows.
- Any condition that, in the opinion of the investigator, contraindicates participation
in this study.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
