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

NCT03187457 | Completed

• 1 other identifier: NH-03708
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vaginal microbiota/lactobacilli levels with Nugent scoring

  Baseline, at day 8, and at day 15

• Diagnosis of BV with "Canestest"

  Baseline

Study Arms (2)

Treatment group

OTHER

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

Other: Metronidazole

Control group

OTHER

Healthy women without Bacterial Vaginosis and without treatment

Other: Control: no treatment

Interventions

Metronidazole OTHER

Women with Bacterial Vaginosis treated with Metronidazole for 5 days

Treatment group

Control: no treatment OTHER

Healthy women without Bacterial Vaginosis

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danisco: lead
• Community Pharmacology Services Ltd: collaborator

Study Sites (1)

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gordon Crawford, MD

  CPS Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: June 15, 2017
• Study Start: September 4, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)