Vaginal DysbiosisDyscoverIINCT04855006
Transplantation of Vaginal Mikrobiome
A study testing Vaginal Microbiome Transplant in people with Vaginal Dysbiosis and Vaginal Microbiome, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dysbiosis, Vaginal Microbiome, Transplantation
- What is being tested?
- Vaginal Microbiome Transplant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transplantation of Vaginal Mikrobiome - A Randomized, Double-blinded, Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Vaginal Microbiome Transplant, Vaginal Microbiome Transplant Placebo, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Microbiome TransplantBiological
Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe
Vaginal Microbiome Transplant PlaceboBiological
Vaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe
No interventionOther
Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 63 days from transplantation
Secondary outcomes (2)
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.
Measured: 7 days from transplantation
Changes in the recipients vaginal bacterial composition
Changes in the recipients vaginal bacterial composition after and during the intervention time
Measured: 63 days from transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jun 2021
- Primary completion1 Jan 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henriette Svarre Nielsen, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855006
- Sponsor's protocol ID
- HH-Dyscover-2021
- Acronym
- DyscoverII
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41905375
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Vaginal Mikrobiome - A Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT04855006
- Acronym / sponsor ID
- DyscoverII / HH-Dyscover-2021
- Conditions
- Vaginal Dysbiosis, Vaginal Microbiome, Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal Microbiome Transplant | Experimental | Biological: Vaginal Microbiome TransplantWomen 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. |
| Vaginal Microbiome Transplant Placebo | Placebo comparator | Biological: Vaginal Microbiome Transplant PlaceboWomen 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. |
| Vaginal Microbiome Donors | Experimental | Other: No interventionWomen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Microbiome TransplantVaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe | Biological | Vaginal Microbiome Transplant |
| Vaginal Microbiome Transplant PlaceboVaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe | Biological | Vaginal Microbiome Transplant Placebo |
| No interventionDonors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'. | Other | Vaginal Microbiome Donors |
Primary outcome
Engraftment of transplanted vaginal microbiome
Time frame: 63 days from transplantation
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.
2 secondary outcomes
Engraftment of transplanted vaginal microbiome after one transplantation
Time frame: 7 days from transplantation
Changes in the recipients vaginal bacterial composition
Time frame: 63 days from transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 41905375Wronding 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Microbiome Transplant in people with Vaginal Dysbiosis and Vaginal Microbiome, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment of transplanted vaginal microbiome (time frame: 63 days from transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.