Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 55 for:    "Vaginitis" | "Metronidazole"

Rwanda Vaginal Microbiota Restoration Study (VMB)

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: NCT02459665
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Rinda Ubuzima, Rwanda
Information provided by (Responsible Party):
Janneke van de Wijgert, University of Liverpool

Brief Summary:
A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence Drug: Prophylactic use of metronidazole pills (500 mg) Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrence Not Applicable

Detailed Description:
This is a pilot study to prepare for larger clinical trials. Sixty-eight HIV-negative, non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV, by modified Amsel criteria and/or Nugent score) and/or Trichomonas vaginalis (TV, on wet mount or by culture) will be treated using oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal candidiasis, other curable sexually transmitted infections (STIs) and urinary tract infection (UTI)), they will be randomised to 4 different vaginal microbiome (VMB) maintenance interventions (17 per group) within 3 days of completing oral metronidazole treatment: 1) Behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2) Behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3) Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5 days immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4) Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days for two months. Vaginal probiotic use may be ceased temporarily during menstruation. Participants will be asked to adhere to the interventions for 2 months, and VMB assessments will take place before (screening and enrolment visits), during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preparing for a Clinical Trial of Interventions to Maintain Normal Vaginal Microbiota for Preventing Adverse Reproductive Health Outcomes in Africa
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : February 23, 2016
Actual Study Completion Date : August 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
No Intervention: Group 1
Negative control group: After initial treatment for BV/TV, no intervention.
Group 2
Positive control group: After initial treatment for BV/TV, metronidazole pills (500 mg) twice per week for 2 months.
Drug: Prophylactic use of metronidazole pills (500 mg)
Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV
Other Name: Tricozole

Active Comparator: Group 3
After initial treatment for BV/TV, Ecologic Femi+ vaginal capsule (a vaginal probiotic) once per day for 5 days immediately after the initial treatment followed by thrice weekly for two months.
Biological: Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence
Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
Other Name: Ecologic Femi+ vaginal capsule

Active Comparator: Group 4
After initial treatment for BV/TV, Gynophilus LP vaginal tablet (a vaginal probiotic) once every 4 days for two months.
Biological: Vaginal Lcr35-containing probiotic for prevention of BV recurrence
Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
Other Name: Gynophilus LP vaginal tablet




Primary Outcome Measures :
  1. Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria [ Time Frame: 2 months (intervention period) ]

    Modified Amsel criteria positive is at least 2 of 3 of the following positive: clue cells, vaginal pH, whiff test.

    Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as denominator of each incidence rate.


  2. Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10) [ Time Frame: 2 months (intervention period) ]
    The Nugent score is a scale from 0-10 based on visualisation of three different bacterial morphotypes on a Gram stained slide, but in the incidence rates, the variable was used as a binary variable: BV present (Nugent score 7-10) or absent (Nugent score 0-6). Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as the denominator for each incidence rate.

  3. Trichomonas Vaginalis (TV) Incidence by Culture [ Time Frame: 2 months (intervention period) ]

    A swab was inoculated into an InPouch culture pouch, specifically designed for TV growth. The pouch was checked daily for five days to detect growth. The results was positive when growth detected and negative when no growth detected on the fifth day.

    Intent-to-treat (ITT) analyses, using person-years (PY) at risk as the denominator for each incidence rate.


  4. Vaginal Candidiasis Incidence by Wet Mount Microscopy [ Time Frame: 6 months: 2 months intervention period plus 4 months after intervention cessation ]
    A wet mount is a smear of vaginal fluid on a microscopy slide, which is examined under a microscope. Yeasts are visible without staining. The definition of vaginal candidiasis was any yeast visible on the wet mount. Symptomatic vaginal candidiasis was considered a safety outcome because treatment of bacterial vaginosis often results in vaginal candidiasis. Intent-to-treat (ITT) analysis with person-years (PY) at risk as the denominator of all incidence rates.


Secondary Outcome Measures :
  1. Vaginal Microbiota Composition by Illumina HiSeq Sequencing: Lactobacillus Genus Concentration [ Time Frame: 2 months (intervention period) ]
    The vaginal microbiota sequencing results are exploratory and full data can be found in a manuscript on the BioRxiv preprint server. The most important outcome is the concentration of Lactobacillus genus in vaginal samples taken at the end of the intervention period (M2 visit).


Other Outcome Measures:
  1. Feasibility/Acceptability of Vaginal Probiotic Use by Structured Face-to-face Interview [ Time Frame: 2 months (intervention period) ]
    Full results have been submitted for publication. Adherence was measured at D7, M1, and M2 visits, and a summary measure over the entire period was calculated (available for women using oral metronidazole, Ecologic Femi+, or Gynophilus LP). After the 2-month intervention period, women using vaginal probiotics (Ecologic Femi+ or Gynophilus LP) were asked structured questions about their experiences with product use.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sexually active, defined as having had sex at least twice in the two weeks prior to screening
  • At high risk of HIV/STIs/BV, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI and/or BV in the last 12 months
  • Successfully treated for BV (modified Amsel criteria) or TV (wet mount), and free of STIs, symptomatic vaginal candidiasis and UTI at enrollment
  • Currently in good physical and mental health as judged by a study physician
  • Willing and able to adhere to study procedures and provide written informed consent.

Exclusion Criteria:

  • Pregnant
  • HIV positive
  • Clinician-observed genital ulcers, condylomata, or other genital abnormalities at screening or enrollment
  • Underwent a gynaecological surgery/invasive procedure in the 3 months prior to screening
  • History of significant urogenital prolapse, undiagnosed vaginal bleeding, urine or faecal incontinence, or blood clotting disorders
  • Allergic to metronidazole or any other components of the study drugs
  • Not willing to stop use of other oral or vaginal probiotics from the screening visit until the end of study participation
  • Participating in another health intervention study
  • For any other reason potentially interfering with participant safety or protocol adherence as judged by the Principal Investigator

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): NCT02459665


Sponsors and Collaborators
Janneke van de Wijgert
Rinda Ubuzima, Rwanda
Investigators
Layout table for investigator information
Study Chair: Janneke H van de Wijgert, PhD University of Liverpool
  Study Documents (Full-Text)

Documents provided by Janneke van de Wijgert, University of Liverpool:
Study Protocol  [PDF] April 22, 2015
Statistical Analysis Plan  [PDF] September 16, 2016


Layout table for additonal information
Responsible Party: Janneke van de Wijgert, Professor of Infection and Global Health, University of Liverpool
ClinicalTrials.gov Identifier: NCT02459665     History of Changes
Other Study ID Numbers: RETH000828
First Posted: June 2, 2015    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: June 2019

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