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MicrobiomeNCT01915251

Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women

An observational study of Microbiome and Antibiotic-Induced VVC, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
How many people
13 participants
Where
1 siteUnited States
Study dates
30 Jul 2013to 10 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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)
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  • 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
  • Immunosuppressive or immune-modulating agents, such as cytokines, methotrexate or other chemotherapies
  • Large doses of commercial probiotics (greater than or equal to 10(8) cfu/day) (ordinary fermented beverages/milks/yogurts/foods are acceptable)
  • Intranasal influenza vaccination due to effects on mucosal immunity
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent
  • Creatinine clearance < 50 mL / min

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Microbiomic and Immunologic Profiling of Women With Antibiotic Induced Vaginal Candidiasis

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.
Read more

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.
Read the detailed description

This protocol is a prospective, interventional, randomized, double-blind, placebo controlled longitudinal study designed to investigate the microbiomic and immunologic perturbations that lead to vulvovaginal candidiasis (VVC) in women who receive antibiotics. VVC is the most common fungal infection affecting women. Although asymptomatic vaginal Candida colonization occurs in ~10-20% of healthy women, ~75% of women will experience at least one episode of symptomatic VVC during their lifetime. Nonetheless, the local mucosal factors that allow Candida to convert from a commensal organism to an opportunistic pathogen are not well defined. Antibiotic use (particularly beta-lactams) is a well-recognized risk factor for the development of VVC in healthy women, suggesting that alterations in the endogenous vaginal microbial flora results in deregulation of local mucosal anti-Candida immune responses. However, which commensal vaginal microbiota are important for protection against Candida infection, and the mechanism(s) whereby vaginal microbiota influence the local mucosal immune response against Candida, remain unknown.

To address these questions, healthy women of reproductive age will receive a 10-day course of amoxicillin (a broad-spectrum, beta-lactam antibiotic) or a placeboand will undergo vaginal sampling for microbiomic and immunologic analyses before, during and after antibiotic administration over a 90-day period. The hypothesis of this study is that women who develop amoxicillin-associated VVC will have a characteristic microbiomic profile (as compared to women with absent or asymptomatic Candida colonization) with associated impairment in local mucosal anti-Candida immune responses. The aim of this study is to elucidate the vaginal microbiomic and immunologic perturbations that allow Candida to transition from commensal to pathogen in the context of antibiotic administration. A better understanding of the role of specific microbiota and mucosal immune factors in averting Candida infection may lead to the design of targeted preventive and/or therapeutic interventions against VVC.

Keywords
Vulvovaginal Candidiasis, Amoxicilin, Microbiome
Medical subject headings
Candidiasis, Vulvovaginal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiomic profile

    Measured: 90-day

  2. Immunologic profile

    Measured: 90 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2013 (estimated)
  2. Study start30 Jul 2013
  3. Primary completion15 Aug 2019
  4. Study completion10 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01915251
Sponsor's protocol ID
130181
Other IDs
13-I-0181
Status last verified
10 Sep 2019
First submitted
30 Jul 2013
Last updated
12 Sep 2019
Results posted
No

Publications

  • 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.

    PubMed 9500475

  • 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.

    PubMed 20534435

  • 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.

    PubMed 16954250

Questions about this trial

What is this clinical trial studying?

An observational study of Microbiome and Antibiotic-Induced VVC, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiomic profile (time frame: 90-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01915251, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.

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