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Trial record 35 of 54 for:    "Vaginitis" | "Metronidazole"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03187457
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Community Pharmacology Services Ltd
Information provided by (Responsible Party):
Danisco

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Other: Metronidazole Other: Control: no treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
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

Control group
Healthy women without Bacterial Vaginosis and without treatment
Other: Control: no treatment
Healthy women without Bacterial Vaginosis




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187457


Locations
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United Kingdom
CPS Research
Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
Danisco
Community Pharmacology Services Ltd
Investigators
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Principal Investigator: Gordon Crawford, MD CPS Research

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Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT03187457     History of Changes
Other Study ID Numbers: NH-03708
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents