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Transplantation of Vaginal Mikrobiome

NCT04855006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2023-03-27

No results posted yet for this study

Summary

Vaginal dysbiosis is a common condition among women. Vaginal dysbiosis covers imbalances in the vaginal flora, caused by the composition of microbes, bacteria, viruses and fungi. Dysbiosis occurs in about 16% of all women in Denmark. A large proportion of women who have vaginal dysbiosis do not experience any symptoms.

However, vaginal dysbiosis can present challenges in several contexts, including a higher tendency for bacterial infections in the female genitals, lower chances of pregnancy in women undergoing fertility treatment, just as it can predispose to premature birth.

This project is aimed at women aged 18-40, who wants to participate in a study to investigate whether, by transplanting vaginal secretion from one woman with a normal vaginal bacterial flora to another woman with an imbalance in the vaginal bacterial flora (called vaginal dysbiosis), can establish a normal vaginal bacterial flora in the recipient of the transplant.

The study will also explore weather genetic, immunological, hormonal, metabolic, health behaviors and clinical factors have significance on whether a normal vaginal flora is achieved after transplantation.

Conditions

  • Vaginal Dysbiosis
  • Vaginal Microbiome
  • Transplantation

Interventions

BIOLOGICAL

Vaginal Microbiome Transplant

Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe

BIOLOGICAL

Vaginal Microbiome Transplant Placebo

Vaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe

OTHER

No intervention

Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-01-01
Completion
2023-03-24

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855006 on ClinicalTrials.gov