PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" (PreFem)

December 12, 2017 updated by: Danisco
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This method validation study will endeavour to obtain evidence for:

  • Recruitment methodology effectiveness
  • The usefulness of the "Canestest" test as a screening tool
  • The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
  • The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent
  • Female gender
  • Over 18 years of age
  • Have a high probability for compliance with and completion of the study

Exclusion Criteria:

  • Hypersensitivity to metronidazole --only applies to Group 2.
  • Post-menopausal defined as at least 12 consecutive months without menstruation
  • Treatment of BV in last 4 weeks
  • Clinically significant menstrual irregularities
  • Suspected presence of STDs or other vaginal infection
  • Pregnancy
  • Breast feeding
  • Participation in other clinical studies which could influence genitourinary tract microbiota
  • Substance abuse
  • Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment group
Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
Other: Metronidazole
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Other: Control group
Healthy women without Bacterial Vaginosis and without treatment
Other: Control: no treatment
Healthy women without Bacterial Vaginosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaginal microbiota assessed with sequencing
Time Frame: Baseline, at day 8, and at day 15
Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)
Baseline, at day 8, and at day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal microbiota/lactobacilli levels with Nugent scoring
Time Frame: Baseline, at day 8, and at day 15
Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment.
Baseline, at day 8, and at day 15
Diagnosis of BV with "Canestest"
Time Frame: Baseline
"Canestest" will be used to diagnose BV infection at baseline.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Collaborators

Community Pharmacology Services Ltd

Investigators

  • Principal Investigator: Gordon Crawford, MD, CPS Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH-03708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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