Clinical trials: Vaginal Microbiome
Human Microbiota, PreTerm Birth
The Reproductive Microbiome & Perinatal Health Outcomes
Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and…
- Conditions
- Human Microbiota, PreTerm Birth, Human Gastrointestinal Microbiota, Metabolomics
- Trial name
- NCT02948192
- Testing
- Survey, Sample collection
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Baylor Research Institute
Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth
Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
This cohort study plans to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.
- Conditions
- Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth, Pregnancy; Infection, Microbial Colonization
- Trial name
- NCT06131749
- Testing
- No intervention
- Where
- South Africa
- Volunteers
- 603 people
- Sponsor
- University of Bern
Bone Marrow Transplant Complications
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy…
- Trial name
- NCT05316740
- Testing
- No intervention
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Hadassah Medical Organization
Overactive Bladder (OAB), Menopause
Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder
The goal of this Pre-Post Quasi-experimental study is to investigates the effect of vaginal estrogen therapy on changes in the urinary microbiome and its association with improvement in overactive bladder (OAB) symptoms in…
- Conditions
- Overactive Bladder (OAB), Menopause, Microbiome
- Trial name
- NCT06780163
- Testing
- 17β-estradiol 10 mcg
- Where
- Thailand
- Volunteers
- 30 people
- Sponsor
- Mahidol University
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
Microbiome, Antibiotic-Induced VVC
Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women
Background: Vaginal yeast infections are caused by a fungus called Candida. Candida can live harmlessly in the vagina, but most women will have symptoms from a vaginal yeast infection at some point during their life.
- Conditions
- Microbiome, Antibiotic-Induced VVC, Vaginal Candidiasis
- Trial name
- NCT01915251
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Vaginal Flora Imbalance
Chlorhexidine Gluconate Versus Povidone-iodine
A hysterectomy, or removal of the uterus, is a common surgery performed for a variety of reasons. During this surgery, to prevent infection, the vagina is thoroughly prepped with a cleansing solution, most commonly chlorhexidine…
- Trial name
- CHDvPI (NCT04658355)
- Testing
- Chlorhexidine Gluconate, Povidone-iodine
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arizona
HSIL, High-Grade Squamous Intraepithelial Lesions, Vaginal Microbiome
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod.
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Vaginal Microbiome, Biomarkers
- Trial name
- NCT06356012
- Testing
- Imiquimod, Loop Electrosurgical Excision Procedure
- Where
- Brazil
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Barretos Cancer Hospital
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Pelvic Organ Prolapse, Hysterectomy
Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy
The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome)…
- Conditions
- Pelvic Organ Prolapse, Hysterectomy, Urinary Tract Infection
- Trial name
- NCT02751073
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Mayo Clinic
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.
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
Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth
Synbiotics in Patients at RIsk fOr Preterm Birth
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause…
- Conditions
- Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth, Microbial Colonization, Microbiome Dysbiosis
- Trial name
- PRIORI (NCT05966649)
- Testing
- Synbiotics
- Where
- 9 sites in Belgium
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- Ziekenhuis Oost-Limburg
Menopause
Estrogen and the Urogenital Microbiome in GSM
This is a study of how local estrogen treatment affects the microbiome of the vagina and bladder in postmenopausal women experiencing symptoms as part of "Genitourinary Syndrome of Menopause." The goal is to understand more about…
- Trial name
- NCT03336437
- Testing
- Estradiol vaginal ring
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Sexually Transmitted Infection
Long-Acting Progestin Contraception and the Vaginal Microbiome
Despite many years of research, controversy persists as to whether hormonal contraception promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone acetate (DMPA) injection showed an increase in HIV…
- Trial name
- vMICROb (NCT02740998)
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Preterm Labor, Preterm Birth
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour.
- Conditions
- Preterm Labor, Preterm Birth, Preterm Premature Rupture of Membrane, Cervical Incompetence
- Trial name
- NCT03992534
- Testing
- LACTIN-V
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
Vulvovaginal Candidiasis
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Female-specific health conditions are underrepresented in research. The taboo felt by women to talk about intimate wellbeing is fed by this gender gap in scientific knowledge.
- Trial name
- DeVEnIR (NCT06397248)
- Testing
- No intervention
- Where
- 3 sites in Belgium
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Bronchopulmonary Dysplasia
The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)
Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
- Trial name
- INFANCY (NCT06342752)
- Testing
- Breath test, Throat swabs, Placental samples
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
HIV/AIDS, Menopause
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen.
- Conditions
- HIV/AIDS, Menopause, Inflammation Vagina
- Trial name
- NCT03218085
- Testing
- Tenofovir, Emtricitabine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Minnesota