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Completed

NCT Number: NCT03187457

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

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

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CPS Research

Glasgow, G20 0XA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole

Other

Women with Bacterial Vaginosis treated with Metronidazole for 5 days

Control: no treatment

Other

Healthy women without Bacterial Vaginosis

Primary outcomes

  1. 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.)

Secondary outcomes

  1. 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.

  2. Diagnosis of BV with "Canestest"

    Time frame: Baseline

    "Canestest" will be used to diagnose BV infection at baseline.

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Collaborators

  • Community Pharmacology Services Ltd

Registry information

Acronym: PreFem

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2017
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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