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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Primary Purpose

Bacterial Vaginoses

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vaginal Microbiome Transplantation (VMT)
Placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginoses

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18-50
  • Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year.
  • Patients are otherwise healthy.
  • Contraception use

Exclusion Criteria:

  • Pregnancy or a planned pregnancy in the upcoming year
  • Infection with HIV.
  • Immunodeficiency status.

Sites / Locations

  • Hadassah Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VMT recipients

Placebo

Arm Description

In order to prevent transfer of pathogens, sperm, or antibiotic-resistant commensals we will establish a "vaginal fluid bank" in which samples from suitable donors will be kept for future use: Donors will be screened using a questionnaire addressing risk factors for potentially transmissible infections, undergo screening for cervico-vaginal infections, cervical cytology screening, and serology analysis for transmittable infections {see detailed screening in Lev-Sagie et al. Nat Med. 2019;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6.} The collected samples for VMT will be examined for bacteria,viruses and sperm. Before transplantation, patients will be treated with intravaginal antibiotics. A frozen specimen will be thawed at room temperature and will be placed in the patient's vagina. Following VMT, patients will be evaluated every 14 days for the first 2 months, then every month for additional 10 months.

Vaginal fluid of all recipients will be collected before initiation of the study using the same protocol, will be clearly labeled and will be kept frozen in similar conditions. These samples will be used in the placebo arm for autologous vaginal fluid transplantation. Before transplantation, patients will be treated with intravaginal antibiotic. Following Placebo, patients will be evaluated every 14 days for the first 2 months, then every month for additional 2-4 months. After 4-6 months, patients who initially received placebo will be offered a VMT in case they are still symptomatic and fulfill inclusion criteria, in an open-label phase.

Outcomes

Primary Outcome Measures

Clinical parameters- patient's complains
Number of participants reporting disappearance of discharge and odor
Laboratory parameters- Amsel criteria
Presence or absence of each Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy)/
Vaginal fluid microscopy
Presence of Lactobacillus-dominant microbiome on microscopy
Microbiome composition
Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing

Secondary Outcome Measures

Full Information

First Posted
August 15, 2020
Last Updated
September 22, 2023
Sponsor
Hadassah Medical Organization
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT04517487
Brief Title
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Official Title
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Weizmann Institute of Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors [Lev-Sagie, Nature Medicine 2019]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission. The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VMT recipients
Arm Type
Active Comparator
Arm Description
In order to prevent transfer of pathogens, sperm, or antibiotic-resistant commensals we will establish a "vaginal fluid bank" in which samples from suitable donors will be kept for future use: Donors will be screened using a questionnaire addressing risk factors for potentially transmissible infections, undergo screening for cervico-vaginal infections, cervical cytology screening, and serology analysis for transmittable infections {see detailed screening in Lev-Sagie et al. Nat Med. 2019;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6.} The collected samples for VMT will be examined for bacteria,viruses and sperm. Before transplantation, patients will be treated with intravaginal antibiotics. A frozen specimen will be thawed at room temperature and will be placed in the patient's vagina. Following VMT, patients will be evaluated every 14 days for the first 2 months, then every month for additional 10 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vaginal fluid of all recipients will be collected before initiation of the study using the same protocol, will be clearly labeled and will be kept frozen in similar conditions. These samples will be used in the placebo arm for autologous vaginal fluid transplantation. Before transplantation, patients will be treated with intravaginal antibiotic. Following Placebo, patients will be evaluated every 14 days for the first 2 months, then every month for additional 2-4 months. After 4-6 months, patients who initially received placebo will be offered a VMT in case they are still symptomatic and fulfill inclusion criteria, in an open-label phase.
Intervention Type
Biological
Intervention Name(s)
Vaginal Microbiome Transplantation (VMT)
Intervention Description
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical parameters- patient's complains
Description
Number of participants reporting disappearance of discharge and odor
Time Frame
12 months
Title
Laboratory parameters- Amsel criteria
Description
Presence or absence of each Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy)/
Time Frame
12 months
Title
Vaginal fluid microscopy
Description
Presence of Lactobacillus-dominant microbiome on microscopy
Time Frame
12 months
Title
Microbiome composition
Description
Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-50 Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year. Patients are otherwise healthy. Contraception use Exclusion Criteria: Pregnancy or a planned pregnancy in the upcoming year Infection with HIV. Immunodeficiency status.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahinoam Lev-Sagie
Phone
+972544327178
Email
levsagie@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahinoam Lev-Sagie
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9765422
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahinoam Lev-Sagie, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31591599
Citation
Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
Results Reference
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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

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