Transplantation of Vaginal Mikrobiome

NCT04855006 | Completed

• 1 other identifier: HH-Dyscover-2021
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Dysbiosis; Vaginal Microbiome; Transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  63 days from transplantation

Secondary Outcomes (2)

• Engraftment of transplanted vaginal microbiome after one transplantation

  7 days from transplantation

• Changes in the recipients vaginal bacterial composition

  63 days from transplantation

Study Arms (3)

Vaginal Microbiome Transplant

EXPERIMENTAL

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 Placebo

PLACEBO COMPARATOR

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 Donors

EXPERIMENTAL

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

Interventions

Vaginal Microbiome Transplant BIOLOGICAL

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

Vaginal Microbiome Transplant

Vaginal Microbiome Transplant Placebo 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 Transplant Placebo

No intervention OTHER

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

Vaginal Microbiome Donors

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Participant eligibility is based on gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: June 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 24, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

DK (1)