Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01915251 · ClinicalTrials.gov registry record
Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 13
- Enrollment target
NCT01915251 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 13 participants.
The verdict
NCT01915251 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 13 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2019-09-10 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915251
The ClinicalTrials.gov registry entry for NCT01915251 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01915251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01915251 about?
NCT01915251 is a clinical study titled "Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women". 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...
What is the current status of trial NCT01915251?
This trial is currently terminated. The enrollment target is 13 participants. The study started on 2013-07-30. Estimated completion is 2019-09-10.
Who is sponsoring clinical trial NCT01915251?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.