Vaginal Flora for Treatment of Bacterial Vaginosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2026-03-31

Brief Summary

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Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.

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Detailed Description

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Conditions

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Recurrent Bacterial Vaginitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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recurrent bacterial vaginitis

Group Type EXPERIMENTAL

vaginal flora transplant

Intervention Type BIOLOGICAL

Interventions

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vaginal flora transplant

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* recurrent BV (4 or more incidences in the past year)
* recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
* 3/4 Amsel criteria and Nugent criteria greater or equal to 7