Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Bacterial Vaginoses Clinical Trial

Official title:

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517487
• Other study ID #: HMO-19-691
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Hadassah Medical Organization
• Contact: Ahinoam Lev-Sagie
• Phone: +972544327178
• Email: levsagie[@]netvision.net.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical parameters- patient's complains	Number of participants reporting disappearance of discharge and odor	12 months
Primary	Laboratory parameters- Amsel criteria	Presence or absence of each Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy)/	12 months
Primary	Vaginal fluid microscopy	Presence of Lactobacillus-dominant microbiome on microscopy	12 months
Primary	Microbiome composition	Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing	12 months