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Transplantation of Vaginal Mikrobiome (DyscoverII)

Primary Purpose

Vaginal Dysbiosis, Vaginal Microbiome, Transplantation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vaginal Microbiome Transplant
Vaginal Microbiome Transplant Placebo
No intervention
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Dysbiosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Vaginal Microbiome Transplant

Vaginal Microbiome Transplant Placebo

Vaginal Microbiome Donors

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Engraftment of transplanted vaginal microbiome
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

Engraftment of transplanted vaginal microbiome after one transplantation
The number of patients who shifts from having a vaginal dysbiosis to not having a vaginal dysbiosis 7 days after the transplant.
Changes in the recipients vaginal bacterial composition
Changes in the recipients vaginal bacterial composition after and during the intervention time

Full Information

First Posted
April 19, 2021
Last Updated
March 24, 2023
Sponsor
Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT04855006
Brief Title
Transplantation of Vaginal Mikrobiome
Acronym
DyscoverII
Official Title
Transplantation of Vaginal Mikrobiome - A Randomized, Double-blinded, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre

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 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.
Detailed Description
06.12.2021 - Amendment to protocol. A subgroup of 24 women included in the main study as recipients, were asked to participate in delivery of menstrual blood (2-3 times) and peripheral blood (2-3 times). This to analyse immunological cells via flowcytometry in women with vaginal dysbiosis and if there is a change after engraftment of the VMT product. 17.05.2022 - Amendment to protocol. Those/if any women who did not convert their vaginal microbiome is asked to participate in a substudy with 2 arms. Local pretreatment with antiseptic and saline water before VMT and local pretreatment with saline water before VMT. 26.09.2022 - Amendment to protocol. Study arm with only pretreatment of antiseptic was added to the amendment from the 17.05.2022.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Dysbiosis, Vaginal Microbiome, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal Microbiome Transplant
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaginal Microbiome Transplant Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Vaginal Microbiome Donors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaginal Microbiome Transplant
Intervention Description
Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe
Intervention Type
Biological
Intervention Name(s)
Vaginal Microbiome Transplant Placebo
Intervention Description
Vaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'.
Primary Outcome Measure Information:
Title
Engraftment of transplanted vaginal microbiome
Description
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.
Time Frame
63 days from transplantation
Secondary Outcome Measure Information:
Title
Engraftment of transplanted vaginal microbiome after one transplantation
Description
The number of patients who shifts from having a vaginal dysbiosis to not having a vaginal dysbiosis 7 days after the transplant.
Time Frame
7 days from transplantation
Title
Changes in the recipients vaginal bacterial composition
Description
Changes in the recipients vaginal bacterial composition after and during the intervention time
Time Frame
63 days from transplantation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hvidovre Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Transplantation of Vaginal Mikrobiome

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