Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01915251
Status:
TERMINATED
Last Update Posted:
2019-09-12
First Post:
2013-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Microbiomic and Immunologic Profiling of Women With Antibiotic Induced Vaginal Candidiasis
Status:
TERMINATED
Status Verified Date:
2019-09-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 13-I-0181 | None | None | View |