Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women (NCT01915251) | Clinical Trial Compass
TerminatedNot Applicable
Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women
United States13 participantsStarted 2013-07-30
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microbiomic profile
Timeframe: 90-day
2
Immunologic profile
Timeframe: 90 day
Trial details
NCT IDNCT01915251
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)