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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: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 13 participants
Start Date 2013-07-30
Est. Completion 2019-09-10

Why NCT01915251 stopped before completion

NCT01915251 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01915251 does not publish any study locations in the registry export this page uses.

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.

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Source: ClinicalTrials.gov NCT01915251, the US trial registry maintained by the National Library of Medicine. NCT01915251 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.