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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT04517487
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Bacterial Vaginoses Biological: Vaginal Microbiome Transplantation (VMT) Biological: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Active Comparator: VMT recipients

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.

Biological: Vaginal Microbiome Transplantation (VMT)
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome

Placebo Comparator: Placebo

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.

Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Clinical parameters- patient's complains [ Time Frame: 12 months ]
    Number of participants reporting disappearance of discharge and odor

  2. Laboratory parameters- Amsel criteria [ Time Frame: 12 months ]
    Presence or absence of each Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy)/

  3. Vaginal fluid microscopy [ Time Frame: 12 months ]
    Presence of Lactobacillus-dominant microbiome on microscopy

  4. Microbiome composition [ Time Frame: 12 months ]
    Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT04517487


Contacts
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Contact: Ahinoam Lev-Sagie +972544327178 levsagie@netvision.net.il

Locations
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Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9765422
Contact: Ahinoam Lev-Sagie, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Weizmann Institute of Science
Investigators
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Principal Investigator: Ahinoam Lev-Sagie Hadassah Medical Center
Publications:
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Responsible Party: Ahinoam Lev-Sagie, Principal investigator, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT04517487    
Other Study ID Numbers: HMO-19-691
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis