Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Body mass index (BMI) greater than or equal to 35 or less than or equal to 18.
- * Age under 18 or over 45.
- * Female who is pregnant or lactating.
- * Irregular bowel movements and/or stool consistency.
- * Plans to travel, move residences, or other major life change during the study period (August-October 2023).
- * Unable to speak, read, and write English.
- * Use of any of the following drugs 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 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. 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.
- * 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 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.
- * 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 cholecystectomy and 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, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
- * chronic constipation.
Ages Eligible for Study
18 Years to 45 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes