DyscoverII: Transplantation of Vaginal Mikrobiome

Sponsor
Copenhagen University Hospital, Hvidovre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04855006
Collaborator
(none)
500
Enrollment
1
Location
3
Arms
18
Anticipated Duration (Months)
27.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Vaginal Microbiome Transplant
  • Biological: Vaginal Microbiome Transplant Placebo
  • Other: No intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Participants are aware if they are allocated as donors or recipients. If the participants are allocated as recipients, they are blinded towards receiving experimental treatment or placebo treatment.
Primary Purpose:
Treatment
Official Title:
Transplantation of Vaginal Mikrobiome - A Randomized, Double-blinded, Controlled Trial
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Vaginal Microbiome Transplant

Women are given the vaginal microbiome transplant at least one time and up to three times. If the woman receives the transplant more than once, it will be 28 days after the first transplant and again 28 days after the second transplant.

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

Placebo Comparator: Vaginal Microbiome Transplant Placebo

Women are given the vaginal microbiome transplant placebo at least one time and up to three times. If the woman receives the transplant more than once, it will be 28 days after the first transplant and again 28 days after the second transplant.

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

Experimental: Vaginal Microbiome Donors

Women allocated in the donor group will donate their vaginal secretion, which will be processed and analyzed throughy before it is used as a transplant. In total, the donors will each provide approximately 10 donations of vaginal secretion.

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

Outcome Measures

Primary Outcome Measures

  1. Engraftment of transplanted vaginal microbiome [63 days from transplantation]

    The number of patients who shifts from having a vaginal dysbiosis to not having a vaginal dysbiosis 7 days after the transplant - up to 3 transplants.

Secondary Outcome Measures

  1. Engraftment of transplanted vaginal microbiome after one transplantation [7 days from transplantation]

    The number of patients who shifts from having a vaginal dysbiosis to not having a vaginal dysbiosis 7 days after the transplant.

  2. Changes in the recipients vaginal bacterial composition [63 days from transplantation]

    Changes in the recipients vaginal bacterial composition after and during the intervention time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Donor:
  • a woman between 18 and 40 years old;

  • generally healthy and do not suffer from an immunological or other chronic diseases;

  • have regular menstruation or do not menstruate due to birth control pills, gestagen pills (mini-pills), etonogestrel birth control implant or hormone IUD;

  • not or do not have a desire to become pregnant within the next year;

  • willing to be asked personal questions in the form of medical history, current use of medication, sexuality and sexual behavior;

  • willing to refrain from vaginal intercourse unless a condom is used during certain periods of participation; and

  • can read and understand information material in Danish or English.

  • Accept not to use any intravaginal products such as tampons, menstrual cup, sex toys, vaginal cleaning products, spermicide products and vaginal lubrication.

Recipient:
  • a woman between 18 and 40 years old;

  • generally healthy and do not suffer from an immunological or other chronic diseases;

  • have regular menstruation or do not menstruate due to birth control pills, gestagen pills (mini-pills), etonogestrel birth control implant or hormone IUD;

  • not or do not have a desire to become pregnant within the next year;

  • willing to be asked personal questions in the form of medical history, current use of medication, sexuality and sexual behavior;

  • willing to refrain from vaginal intercourse unless a condom is used during certain periods of participation; and

  • can read and understand information material in Danish or English.

  • Accept not to use any intravaginal products such as tampons, menstrual cup, sex toys, vaginal cleaning products, spermicide products and vaginal lubrication.

Exclusion Criteria:
Donor:
  • Being pregnant

  • Any medical history of bacterial vaginosis, Trichomoniasis, Syphilis, HPV, herpes, intraabdominal infections, recurrent urine infections or Mycoplasma infections.

  • Positive test result of HIV, Hepatitis A, B and C, Chlamydia, Gonorré, Mycoplasma, Trichonomas, HPV, herpes simplex and Streptococcus A, B, C and G.

  • Currently pregnant or lactating.

  • Any history of Gonorré and/or Chlamydia during the last year.

  • Have been travelling or have had a sexual partner who has been travelling to countries with Ebola and/or Zika virus within the last year.

  • Any other medical history, current use of medicine, travels or behavior which from a doctor's perspective is considered not suitable for being a donor.

  • Hysterectomized

  • Have participated in other medical studies within the last 30 days

  • Removal of IUD, cervical cryotheraphy or cervical laser-treatment up until 3 months before screening.

  • Any condition requiring the use of antibiotics in the investigation period

  • Usage of long-acting hormonal therapy within the last 3 months prior to screening.

  • Any social, medical or psychological condition including any history of drug and alcohol abuse, where it is evaluated that the participant cannot adhere to the protocol

  • Unsatisfying examination and screening results evaluated by a doctor

  • Any sexual habits, history or sexual partner, where the behavior can lead to an increased risk of sexual infections.

  • Usage of medicine, recently vaccinated or other behavior which is considered to be a hinder for participation.

Recipient:
  • Being pregnant

  • Planning to become pregnant within the next 6 months

  • Lactating

  • Being less than 8 weeks post partum

  • Known positive HIV/AIDS infection or other immune diseases

  • Positive test result of HIV, Hepatitis A, B and C, Chlamydia, Gonorré, Mycoplasma, Trichonomas, positive urine hCG and HPV.

  • Have participated in other medical studies within the last 30 days

  • Removal of IUD, cervical cryotheraphy or cervical laser-treatment up until 3 months before screening.

  • Any condition requiring the use of antibiotics in the investigation period

  • Usage of long-acting hormonal therapy within the last 3 months prior to screening.

  • Any social, medical or psychological condition including any history of drug and alcohol abuse, where it is evaluated that the participant cannot adhere to the protocol

  • Unsatisfying examination and screening results evaluated by a doctor

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hvidovre HospitalCopenhagenHvidovreDenmark2650

Sponsors and Collaborators

  • Copenhagen University Hospital, Hvidovre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henriette Svarre Nielsen, MD, DMSc, Professor, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT04855006
Other Study ID Numbers:
  • HH-Dyscover-2021
First Posted:
Apr 22, 2021
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2021