Transplantation Clinical Trial
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. 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00778856 -
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
|
N/A | |
Completed |
NCT00838357 -
A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).
|
Phase 3 | |
Active, not recruiting |
NCT00166842 -
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|
Phase 4 | |
Recruiting |
NCT04257747 -
Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
|
N/A | |
Completed |
NCT02560909 -
Adjuvanted Influenza Vaccine in Stem Cell Transplant
|
Phase 4 | |
Active, not recruiting |
NCT01687192 -
Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.
|
Phase 2 | |
Completed |
NCT00951977 -
Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study
|
N/A | |
Completed |
NCT00384137 -
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
|
Phase 3 | |
Completed |
NCT00384202 -
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
|
Phase 3 | |
Completed |
NCT00235664 -
Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients
|
N/A | |
Completed |
NCT03533049 -
mHealth Family Self-Management
|
N/A | |
Completed |
NCT02826213 -
Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
|
||
Completed |
NCT00170170 -
Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation
|
N/A | |
Recruiting |
NCT06367244 -
Transplant Wellness Program
|
N/A | |
Recruiting |
NCT06166186 -
Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy
|
N/A | |
Recruiting |
NCT00493194 -
Fibrosis in Renal Allografts
|
Phase 4 | |
Completed |
NCT00297310 -
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
|
Phase 4 | |
Completed |
NCT01019811 -
Innervated Sensory Cross-Finger Flap
|
N/A | |
Completed |
NCT04376775 -
Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation
|
||
Active, not recruiting |
NCT00166816 -
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
|
Phase 4 |