Clinical trials: Vaginal Microbiome
Cytolytic Vaginosis
Cytolytic Vaginosis Multicentre Registry
The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are: What are risk factors of cytolytic vaginosis? Are there…
- Trial name
- NCT06228469
- Where
- 3 sites in Brazil, Canada and 1 more
- Volunteers
- 32 people
- Sponsor
- University of Alberta
HIV -1 Infection
Safety Study of MucoCept-CVN
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug.
- Trial name
- NCT07181486
- Testing
- Live Biotherapeutic Product L. jensenii 1153-1666
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Craig Cohen, MD, MPH
Recurrent Pregnancy Loss, Not Pregnant, Vaginal Microbiome
Uterine Microbiome in Recurrent Pregnancy Loss
The female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. Disturbances in this microbiome may be associated with adverse reproductive outcomes.
- Trial name
- NCT05510622
- Testing
- Vaginal swab and endometrial biopsy
- Where
- 2 sites in Vietnam
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mỹ Đức Hospital
Endometriosis, Infertility
Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope.
- Conditions
- Endometriosis, Infertility, Female Fertility, Cell Free DNA
- Trial name
- PestiEndoMicro (NCT07471373)
- Testing
- Circulating DNA analysis, Vaginal microbiota analysis, Endometrial microbiota analysis
- Where
- France
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Vulvovaginal Candidiasis
VVC Sampling Study for Analysis Validation
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.
- Trial name
- NCT05327192
- Testing
- No intervention, only sampling
- Where
- 2 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Gedea Biotech AB
Genitourinary Syndrome of Menopause
Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause
Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH…
- Trial name
- NCT06873971
- Testing
- Topical estrogen therapy based on estriol (E3), Active Er:YAG Laser
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Nove de Julho
Urinary Tract Infections, Vaginal Flora Imbalance
Vaginal Care System for Menopausal Women With Urinary Tract Infections
Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause.
- Trial name
- NCT05573334
- Testing
- BioNourish
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Vaginal Biome Science
Vaginal Microbiome
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
The vaginal microbiome plays a crucial role in women's health and reproduction, impacting not only women but also their partners and children. However, its ecology and primary colonizers are not well understood.
- Trial name
- Maggie (NCT06912126)
- Where
- Belgium
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Pelvic Floor Disorders
Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth.
- Trial name
- NCT05665569
- Testing
- Flourish HEC, which contains BioNourish, Routine pelvic physical therapy
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Vaginal Biome Science
Infertility
Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase in Assisted Reproduction
Rationale: The hormone progesterone has different functions. In pregnancy, it is vital for maintenance thereof. In early pregnancy, progesterone is synthesized by the Corpus luteum (CL).
- Trial name
- NCT03507673
- Testing
- Blood samples and microbiological swaps
- Where
- 5 sites in Germany
- Volunteers
- 1,200 people
- Sponsor
- University of Luebeck
Vaginosis, Bacterial, Bacterial Vaginosis
Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis
The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections.
- Conditions
- Vaginosis, Bacterial, Bacterial Vaginosis, Bacterial Vaginosis (BV)
- Trial name
- GYNBAL-RBV (NCT07527572)
- Testing
- Lactobacillus gasseri KABP®064 10e9 CFU/capsule
- Volunteers
- 160 people
- Sponsor
- Kaneka Americas Holding Inc.
Human Papilloma Virus, Vaginal Flora Imbalance
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to…
- Conditions
- Human Papilloma Virus, Vaginal Flora Imbalance, Cancer Cervix Uterus, Cervical Dysplasia
- Trial name
- NCT05640700
- Where
- Israel
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Bacterial Vaginosis
Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.
- Trial name
- NCT06263465
- Testing
- Lactobacillus cispatus
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Zhujiang Hospital
Vulva; Atrophy
Efficacy and Safety of CO₂ Laser Therapy Combined With Collagen Cream in Managing Vulvo-Vaginal Atrophy: A Randomized, Controlled Study on Symptom Relief and Microbiome Modulation
This study evaluated a new treatment for postmenopausal women suffering from vulvo-vaginal atrophy (VVA), a condition that causes dryness, burning, and pain.
- Trial name
- NCT07246616
- Testing
- SmartXide2 treatment plus the application of Palingen cream, Laser Therapy Only (Control Group)
- Where
- San Marino
- Volunteers
- 60 people
- Sponsor
- Institute for Social Security, Republic of San Marino
Fertility Disorders
Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment
It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60).
- Trial name
- NCT04641390
- Testing
- Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment, Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Instituto Bernabeu
Bacterial Vaginosis, Vaginal Microbiome
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV.
- Conditions
- Bacterial Vaginosis, Vaginal Microbiome, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
- Trial name
- POWWERHealth (NCT05666778)
- Testing
- Menstrual Cup
- Where
- 2 sites in United States, Kenya
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Vaginal Microbiota, Microbiota
Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women
The goal of this clinical trial was to learn whether the vaginal microbiota changed after healthy women aged 18 to 45 years took Hifas Intima, an oral food supplement, for 3 months.
- Conditions
- Vaginal Microbiota, Microbiota, Vaginal Microbiome
- Trial name
- NCT07715058
- Testing
- Hifas INTIMA Oral
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hifas da Terra S.L.
Vaginal Flora Imbalance
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on…
- Trial name
- DYSCOVER-1 (NCT05114031)
- Testing
- FB101
- Where
- Ireland
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Freya Biosciences ApS
Urinary Tract Infections
Effects of Flourish on Recurrent Urinary Tract Infection
An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.
- Trial name
- NCT05397782
- Testing
- BioNourish, a component of Flourish HEC
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Vaginal Biome Science
Vaginal Microbiome, Skin Microbiome
Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to…
- Conditions
- Vaginal Microbiome, Skin Microbiome, Saliva Microbiome
- Trial name
- Isala (NCT04319536)
- Testing
- no intervention
- Where
- Belgium
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp