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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Microbiome Transplant | Biological | Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days from transplantation |
| Changes in the recipients vaginal bacterial composition |
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Inclusion Criteria:
Donor:
Recipient:
Exclusion Criteria:
Donor:
Recipient:
Participant eligibility is based on gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Copenhagen | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41905375 | Derived | Wronding T, Vomstein K, Lundgaard AT, DeLong K, Mollerup S, Mortensen B, Bosma EF, Hellerung AM, Engel EV, Wiil KD, Heintz JE, Halkjaer SI, Hugerth LW, Hartwig TS, Petersen AM, Thomsen AB, Westergaard D, la Cour Freiesleben N, Westh H, van Hylckama Vlieg JET, Ensign LM, Nielsen HS. Vaginal microbiota transplantation for treatment of vaginal dysbiosis without the use of antibiotics: a double-blind, randomised controlled trial in women with vaginal dysbiosis. Lancet Microbe. 2026 Apr;7(4):101294. doi: 10.1016/j.lanmic.2025.101294. Epub 2026 Mar 26. |
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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.
| 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 |
|
| No intervention | Other | Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'. |
|
Changes in the recipients vaginal bacterial composition after and during the intervention time |
| 63 days from transplantation |