Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women

NCT01915251 | Terminated

• 2 other identifiers: 13018113-I-0181
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbiome; Antibiotic-Induced VVC; Vaginal Candidiasis

Keywords

Vulvovaginal Candidiasis; Amoxicilin; Microbiome

Outcome Measures

Primary Outcomes (2)

• Microbiomic profile

  90-day

• Immunologic profile

  90 day

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females 18-40 years of age must meet the following criteria to be eligible for participation in this study:
• Willing and able to comply with the procedures of the protocol
• Able to provide informed consent
• Able to swallow capsules
• Have a history of regular (approximately 21-35 day) menstrual cycles prior to initiation of hormonal contraception
• On oral contraceptives for at least 3 months prior to sampling (see Participation of Women below)
• Participation of Women:
• Contraception:
• Because menstruation is known to affect the vaginal microbiome and because oral contraceptives produce predictable menstrual cycles, subjects must be on oral contraceptives in order to be eligible for the study. Additionally, since amoxicillin may theoretically reduce the efficacy of oral contraceptives, subjects must agree to use an additional form of contraception (barrier method, abstinence) while receiving the study drug.

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Sobel JD, Faro S, Force RW, Foxman B, Ledger WJ, Nyirjesy PR, Reed BD, Summers PR. Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations. Am J Obstet Gynecol. 1998 Feb;178(2):203-11. doi: 10.1016/s0002-9378(98)80001-x.

  PMID: 9500475 BACKGROUND

• Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.

  PMID: 20534435 BACKGROUND

• Pirotta MV, Garland SM. Genital Candida species detected in samples from women in Melbourne, Australia, before and after treatment with antibiotics. J Clin Microbiol. 2006 Sep;44(9):3213-7. doi: 10.1128/JCM.00218-06.

  PMID: 16954250 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Michail S Lionakis, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 2, 2013
• Study Start: July 30, 2013
• Primary Completion: August 15, 2019
• Study Completion: September 10, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09-10

Locations

US (1)