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

Bacterial Vaginosis Clinical Trial

— PreFem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187457
• Other study ID #: NH-03708
• Status: Completed
• Phase: N/A
• First received: May 18, 2017
• Last updated: December 12, 2017
• Start date: September 4, 2017
• Est. completion date: November 14, 2017

Study information

• Verified date: December 2017
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginosis, Bacterial

Intervention

Other:
• Metronidazole
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
• Control: no treatment
Healthy women without Bacterial Vaginosis

Locations

Country	Name	City	State
United Kingdom	CPS Research	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Danisco	Community Pharmacology Services Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Baseline, at day 8, and at day 15
Secondary	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.	Baseline, at day 8, and at day 15
Secondary	Diagnosis of BV with "Canestest"	"Canestest" will be used to diagnose BV infection at baseline.	Baseline