This study is currently recruiting participants.
Number
16-I-0078
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 49 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Microbiome; Amoxicillin; Azithromycin; Stool; Healthy
Recruitment Keyword(s)
None
Condition(s)
Normal Physiology; Healthy
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Amoxicillin Drug: Azithromycin Other: Control
Supporting Site
National Institute of Allergy and Infectious Diseases
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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.
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.
Principal Investigator
Referral Contact
For more information: