Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women

Stopped early

Conditions studied: Microbiome, Antibiotic-Induced VVC, Vaginal Candidiasis

In brief

Background: \- Vaginal yeast infections are caused by a fungus called Candida. Candida can live harmlessly in the vagina, but most women will have symptoms from a vaginal yeast infection at some point during their life. Antibiotics increase the risk for yeast infections, but it is unclear why. They may disrupt the balance of healthy bacteria in the vagina. This could make it harder for the body to fight off yeast infections. Researchers will give healthy women a common antibiotic or a placebo. They will study how the antibiotic affects bacteria and yeast in the vagina and other parts of the body. This will let researchers study the normal changes of healthy bacteria and yeast over time. Objectives: \- To see how the study drug changes healthy bacteria in the vagina, and how these changes may increase the risk for yeast infections. Eligibility: \- Healthy women ages 18 to 40 who are not allergic to penicillin. Design: * Participants will be screened with medical history, physical exam (including vaginal exam), blood tests and tests for sexually transmitted diseases. * Participants must take birth control pills for at least 3 months before, and during the study. * Participants will take the study antibiotic or placebo for 10 days. * Participants will have 7 study visits over 3 months. Visits will be timed around participants menstrual cycles. * At the visits, participants will answer questions about their health and undergo tests. These may include swabs of the vagina, mouth and skin as well as blood tests. Vaginal fluid, saliva and urine will also be collected. * Between visits, participants will collect stool and vaginal samples at home and bring them to the next clinic visit.

Key facts

Study ID

NCT01915251

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

13

Starts

2013-07-30

Expected to finish

2019-09-10

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• A subject will not be eligible if she has any of the following:
• Pregnancy
• Breastfeeding
• Known allergy to beta-lactam antibiotics (e.g., penicillin)
• Body mass index (BMI) greater than or equal to 35 or less than or equal to 18 at screening visit
• Vital signs outside of acceptable range at screening visit (i.e. blood pressure > 160/100, oral temperature > 100 degrees F, pulse > 100)
• Primary or acquired immunodeficiency, including Human Immunodeficiency Virus (HIV) (diagnosed via an FDA-approved test)
• Hepatitis C seropositivity or positive Hepatitis B surface antigen
• Chronic, clinically significant (requiring on-going medical management or medication) pulmonary, cardiovascular, dermatologic, endocrine, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history and physical examination and/or laboratory testing (Complete blood count [CBC] with differential, Acute Care Panel, Hepatic Panel)
• Active malignancy or history of malignancy for which there is not reasonable assurance of sustained cure
• Major surgery of the gastrointestinal tract, including any major bowel resection at any time, with the exception of cholecystectomy and appendectomy, in the past five years
• Genitourinary/Gynecologic conditions, including:
• Urinary incontinence necessitating use of incontinence protection garments
• Treatment for or suspicion of ever having had toxic shock syndrome
• History of hysterectomy
• History of vulvar, vaginal or cervical dysplasia within the previous 5 years
• History of condyloma or human papillomavirus (HPV) diagnosed within the previous 2 years
• History of candidiasis, urinary tract infection, or STD (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
• Chronic smokers and subjects who use smokeless tobacco products (due to known effects of tobacco on the oral microbiome)
• Exposures to the following agents (which could affect the microbiome) within 6 months prior to sampling:
• Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous (IV), intramuscular (IM) or oral)
• Vulvar/vaginal antifungal or hormonal medications
• Intrauterine device (IUD) or hormonal vaginal ring (e.g. Nuvaring) due to unknown duration of local hormone effects
• Oral, IV, IM, nasal or inhaled corticosteroids, or use of high-dose topical steroids in areas to be sampled

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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