Transplantation of Vaginal Mikrobiome

NCT ID: NCT04855006

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-03-24

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.

Conditions

Vaginal Dysbiosis; Vaginal Microbiome; Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaginal Microbiome Transplant

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

Vaginal Microbiome Transplant Placebo

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

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

Interventions

Vaginal Microbiome Transplant

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

No intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Henriette Svarre Nielsen

MD, DMSc, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Countries

Denmark

Other Identifiers

HH-Dyscover-2021

Identifier Type: -

Identifier Source: org_study_id