Status:
COMPLETED
Transplantation of Vaginal Mikrobiome
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Conditions:
Vaginal Dysbiosis
Vaginal Microbiome
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 a...
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 time...
Eligibility Criteria
Inclusion
- 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 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT04855006
Start Date
June 1 2021
End Date
March 24 2023
Last Update
March 27 2023
Active Locations (1)
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1
Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650