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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metronidazole
Control: no treatment
Sponsored by
Danisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CPS Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Treatment group

Control group

Arm Description

Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection

Healthy women without Bacterial Vaginosis and without treatment

Outcomes

Primary Outcome Measures

Change in vaginal microbiota assessed with sequencing
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.)

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2017
Last Updated
December 12, 2017
Sponsor
Danisco
Collaborators
Community Pharmacology Services Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03187457
Brief Title
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Acronym
PreFem
Official Title
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danisco
Collaborators
Community Pharmacology Services Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Other
Arm Description
Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
Arm Title
Control group
Arm Type
Other
Arm Description
Healthy women without Bacterial Vaginosis and without treatment
Intervention Type
Other
Intervention Name(s)
Metronidazole
Intervention Description
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Intervention Type
Other
Intervention Name(s)
Control: no treatment
Intervention Description
Healthy women without Bacterial Vaginosis
Primary Outcome Measure Information:
Title
Change in vaginal microbiota assessed with sequencing
Description
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.)
Time Frame
Baseline, at day 8, and at day 15
Secondary Outcome Measure Information:
Title
Vaginal microbiota/lactobacilli levels with Nugent scoring
Description
Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment.
Time Frame
Baseline, at day 8, and at day 15
Title
Diagnosis of BV with "Canestest"
Description
"Canestest" will be used to diagnose BV infection at baseline.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Crawford, MD
Organizational Affiliation
CPS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPS Research
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD

Learn more about this trial

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

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