2025-524362-20-00招募中2 期
Open-label safety and efficacy trial of chlorhexidine and/or metronidazole pre-treatment followed by FB301 in women with bacterial vaginosis (BV)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).
研究概览
简要总结
To assess the impact on change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged 18 to 45 years of age inclusive, at the time of signing the informed consent.
- •Willing to undergo vaginal cleansing and treatment procedures, including self-administration of IMP, where required, at home.
- •Willing to abstain from vaginal intercourse, following the first FB301 treatment until the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
- •Willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the Investigator following the first FB301 treatment until the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
- •Willing and able to comply with trial procedures and attending scheduled visits.
- •No changes in medical conditions or prior/concomitant therapy also regarding adherence to sexual behavior and contraceptive/barrier requirements.
- •Participants with an untreated suspected or confirmed symptomatic BV presenting with characteristic vaginal discharge and/or fishy odor confirmed by Gram stain of the vaginal specimen having a Nugent Score of equal or above 7 at the screening visit.
- •Participant is otherwise in good physical and mental health, as determined by the Investigator.
- •BMI up to 37 kg/m2 (inclusive).
- •Premenopausal female patients Using oral, transdermal (patches), or injectable/implantable contraceptives or hormonal IUS (non-hormonal IUD is not allowed) within the last 3 months prior to screening must be willing not to change their method of contraception during the trial. OR Not using any hormonal method of contraception must be willing not to start any other method of contraception during the trial. They must use condoms after the period in which no sexual activity is allowed, i.e., following the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
- •Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives
- •Willing to be asked questions about reproductive/sexual activity and use of vaginal products.
- •Willing to provide and self-collect cervicovaginal secretions and vaginal swab samples at the clinic and at home.
排除标准
- •Known immunodeficiency conditions, including drug induced.
- •Participants taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks or 5 half-lives (whichever is longer) before the start of trial treatment (unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial).
- •Receiving treatment involving investigational drugs. Any previous investigational drug must have been completed at least 30 days prior to screening in this trial.
- •Systemic and/or vaginally applied antibiotic use within the last 30 days prior to screening.
- •Participants who are currently receiving antibacterial therapy unrelated to BV.
- •Clinical laboratory test results which are clinically unacceptable at screening. Any clinically significant abnormal urinalysis should be repeated. If then confirmed abnormal and clinically significant, participant should be excluded. Any clinically significant out of range chemistry or hematology values should exclude the participant.
- •Positive serum HBsAg (other than vaccination related), HCV and HIV antibody tests at screening.
- •Positive test for Treponema pallidum (syphilis).
- •Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).
- •Aural body temperature of < 35.5 or > 37.6°C at screening.
- •Pregnant, breastfeeding, has been pregnant within the last 2 months, or wishes to become pregnant within the next 6 months. Egg donation during the trial is not permitted.
- •Contraindication to metronidazole or chlorhexidine.
- •Use of a copper IUD (intrauterine device) within 12 weeks of screening. (Hormonal IUDs are permitted.)
- •Use of probiotics, prebiotics or symbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods).
- •Donation of more than 100 mL whole blood or plasma within 4 weeks before start of treatment or more than 500 mL of whole blood 3 months before start of treatment or intended blood donation during the trial.
- •History of alcohol or substance dependency.
- •Employee of the Sponsor, the CRS Group, or other CRO involved in the clinical trial.
- •Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.
- •Changes in medical conditions compared to screening which would lead to the exclusion of the participant, as assessed by the Investigator.
- •Changes in prior/concomitant therapy compared to screening, as judged by the Investigator.
- •Positive screen for alcohol or drugs of abuse on the first dosing day.
- •Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).
- •Any known condition requiring regular use of antibiotics, which would suggest the likely requirement for antibiotic treatment during the trial.
- •Aural body temperature of < 35.5 or > 37.6°C on Day
- •Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.
- •Any social, medical, or psychiatric condition that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial requirements or might interfere with the objectives of the trial.
- •History of drug or alcohol abuse that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial or would complicate interpretation of data from participation.
- •History of gynecological cancers, gynecological conditions, or surgical gynecological medical history which, in the opinion of the Investigator, precludes participation.
- •Abnormal finding on the physical examination or gynecological examination or any other condition which, in the opinion of the Investigator, precludes participation.
- •Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or active Herpes simplex [including PCR test positive]).
- •Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response.
结局指标
主要结局
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).
次要结局
- The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
- The change in vaginal microbiome in terms of relative abundance of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
- The change in vaginal microbiome in terms of relative abundance of Bifidobacterium spp. (previously Gardnerella spp.), Atopobium spp., and Fannyhessea spp. measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
- Frequency and intensity of all AEs including frequency and grade of the AESIs. Clinically significant changes in clinical chemistry and hematology will also be evaluated.
- Proportion of participants with microbiological cure defined as Nugent Score of less than 4 at Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10). Proportion of participants with clinical cure, defined as resolution of abnormal vaginal discharge, negative Whiff test, pH and presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount at Visit 3 (Week 3), Visit 5 (Week 7), and Visit 6 (Week 10).
研究者
Clinical Department
Scientific
Freya Biosciences ApS
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled TrialNCT07344064Queen Savang Vadhana Memorial Hospital, Thailand80
已完成
不适用
Postbiotic Intervention on Vaginal MicrobiotaNCT07278024Kaohsiung Veterans General Hospital.15
已完成
不适用
Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in ObesityNCT07266532Shenzhen People's Hospital98
尚未招募
不适用
Couples and Microbial DiversityInfertilityNCT07315568Tampere University Hospital200
招募中
1 期
Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome EvaluationNeurogenic BladderNCT07308808Medstar Health Research Institute40