Clinical trials: Vaginal Microbiome
Implantation Failure, Infertility, Female
Modulating the Vaginal Microbiome After Implantation Failure
Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal…
- Conditions
- Implantation Failure, Infertility, Female, Vaginal Flora Imbalance
- Trial name
- NCT03843112
- Testing
- Vivag Plus
- Where
- Denmark
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Zealand University Hospital
Bacterial Vaginosis, Microbial Colonization
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence.
- Trial name
- NCT05963711
- Testing
- chlorhexidine gluconate 4%
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Healthy
Pubic Hair and the Urinary and Vaginal Microbiome
This research study seeks to find if there is a connection between the presence of pubic hair and the type of bacteria that live in the vagina and bladder.
- Trial name
- NCT03272204
- Testing
- No pubic hair, Pubic Hair
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Margaret Mueller
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
C-section, Vaginal Seeding
MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children.
- Conditions
- C-section, Vaginal Seeding, Respiratory, Microbiome
- Trial name
- MOTHER SEED (NCT05505110)
- Testing
- Vaginal Seeding, Sterile Swab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vanderbilt University Medical Center
Effects of Menstrual Products on the Vaginal Microbiome
Improving Menstrual and VAginal Health for All
A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and…
- Trial name
- IMVAHA (NCT06646185)
- Testing
- Menstrual Pads, Menstrual Cups, Tampons
- Where
- 3 sites in Cameroon, Peru and 1 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Swiss Tropical & Public Health Institute
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
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
Cesarean Delivery Affecting Newborn, Obesity, Childhood
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham.
- Conditions
- Cesarean Delivery Affecting Newborn, Obesity, Childhood, Intestinal Microbiome, Microbiota
- Trial name
- NCT03298334
- Testing
- Vaginal Seeding, No Vaginal Seeding
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Recurrent UTIs
Genitourinary Study of Fostering Lactobacillus to Optimize the Microbiome in Women's Health (GUD-FLORA)
The objective of this study is to evaluate the use of a vaginal probiotic in patients with recurrent urinary tract infections (UTIs).
- Trial name
- GUD-FLORA (NCT07234227)
- Testing
- Lactobacillus crispatus probiotic
- Sponsor
- Duke University
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
- 90 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Candidiasis, Vulvovaginal
Vulvovaginal Candidiasis in Canadian Females
Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life.
- Trial name
- THRIVE-yeast (NCT04930107)
- Testing
- Fluconazole 150 mg, Boric Acid Supp,Vag
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Menopause, Hormone Replacement Therapy
Menopausal Vaginal Microbiome
In this study the investigators will analyze the vaginal microbiome of menopausal women in order to shed light on its potential implication on menopausal symptoms and quality of life.
- Conditions
- Menopause, Hormone Replacement Therapy, Genitourinary Syndrome of Menopause
- Trial name
- NCT05122065
- Volunteers
- 432 people, healthy volunteers welcome
- Sponsor
- FemTec Health Inc.
Bacterial Vaginosis
Flourish HEC to Prevent Recurrence of BV
In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.
- Trial name
- NCT05386147
- Testing
- Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Vaginal Biome Science
Infertility, Female
Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.
Is already demonstrated that around 30% of patients undergoing an artificial cycle with vaginal progesterone do not reach a minimum threshold value of serum progesterone levels on the day of embryo transfer.
- Trial name
- PROGEBIOMA (NCT05161338)
- Testing
- MICROBIOME GENETIC ANALYSIS, VAGINAL PH VALUE, SERUM PROGESTERONE LEVELS
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
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
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
Preterm Birth, Preterm Labor
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth).
- Conditions
- Preterm Birth, Preterm Labor, Multiple; Pregnancy, Complicated, Twin Dichorionic Diamniotic Placenta
- Trial name
- SPRUCE (NCT06053697)
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Liverpool
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
Vaginal Odor
The Effects of an Orally-Administered Probiotic on Vaginal Symptoms
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms.
- Trial name
- NCT07829861
- Testing
- Orally-administered probiotic
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Bonafide Health