Transplantation of Vaginal Mikrobiome (NCT04855006) | Clinical Trial Compass
CompletedNot Applicable
Transplantation of Vaginal Mikrobiome
Denmark302 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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 inf…