Clinical trials: Vaginal Microbiome
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
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
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
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
Healthy
Vaginal Microbiome Research Consortium for Africa
1. To characterise vaginal microbial community dynamics (bacterial and fungal) from different geographies in Africa to understand the microbial diversity that occurs in women with stable L.
- Trial name
- VMRC4Africa (NCT06662747)
- Testing
- None - observational study only
- Where
- 2 sites in Kenya, South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Bacterial Vaginosis, Vulvovaginal Candidiasis
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome.
- Trial name
- NCT05753813
- Testing
- Phexxi
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Queen's Medical Center
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
Preterm Birth, Microbial Colonization
Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth
Microbiota contributes to the immunological, hormonal and metabolic homeostasis of the host. As in all natural orifices in the body, there is also a microbiota and mycobiota specific to the vagina.
- Trial name
- NCT04165252
- Testing
- Collection of vaginal, neonatal buccal and placental samples
- Where
- Turkey (Türkiye)
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Koç University
Bacterial Vaginosis, Candidiasis
Vaginal Ecosystem and Network in the United States Study
The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions.
- Conditions
- Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause
- Trial name
- VENUS (NCT06472765)
- Testing
- Vaginal Swab Collection
- Where
- 21 sites in United States, Canada
- Volunteers
- 3,250 people, healthy volunteers welcome
- Sponsor
- Vaginal Biome Science
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
Premature Ovarian Insufficiency, Reproductive Health
Microbiome and Premature Ovarian Insufficiency
This study investigates the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers.
- Trial name
- NCT07275671
- Where
- 2 sites in China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Westlake University
Perimenopause, Menopausal Symptoms
A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women
The goal of this consumer health study is to evaluate the effect of resW™ Perimenopause Postbiotic on menopausal symptom severity, menopause-related quality of life, and selected microbiome-related outcomes in generally healthy…
- Conditions
- Perimenopause, Menopausal Symptoms, Menopause-Related Quality of Life, Microbiome
- Trial name
- RESW101 (NCT07570043)
- Testing
- Supplement
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Able Biolabs, LLC
Breast Neoplasms
Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study
This study evaluates vaginal microbiome as a biomarker to improve vaginal and sexual health in women with breast cancer receiving endocrine therapy.
- Trial name
- NCT05946668
- Testing
- Biospecimen Collection, Electronic Health Record Review, Questionnaire Administration
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Obesity & Overweight, Perimenopausal Women
Prebiotic Inulin for Late-Reproductive Individuals
This study aims to evaluate the effects of 2 weeks of inulin supplementation in perimenopausal women with overweight or obesity. The primary questions this study seeks to answer are: 1.
- Conditions
- Obesity & Overweight, Perimenopausal Women, Prebiotics, Inulin
- Trial name
- PILI (NCT07724522)
- Testing
- Inulin
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- George Washington University
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
Dysbiosis, Inflammation Gum
Microbiome Alterations With Xylitol (MAX) in Pregnancy
The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation…
- Conditions
- Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata
- Trial name
- MAX (NCT06329596)
- Testing
- Xylitol gum, Sorbitol gum
- Where
- Malawi
- Volunteers
- 80 people
- Sponsor
- Baylor College of Medicine
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 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 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
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