CTRI/2022/10/046723尚未招募2 期
A Double blind, Randomized, Placebo-controlled, Parallel Clinical Trial to Evaluate the Clinical Efficacy and Safety of Vaginal Probiotic Capsule (LABTHERA-001) in patients with Bacterial Vaginosis
Atogen Co., Ltd.3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 1. Reduction in Amsel Criteria
研究概览
简要总结
Bacterial vaginosis (BV) is an infection of the vagina characterized by overgrowth of certain types of bacteria which leads to change in normal balance of vaginal microbiome. The signs and symptoms of Bacterial Vaginosis includes thin, grey,white or green vaginal discharge, foul-smelling "fishy" vaginal odor, vaginal itching or burning sensation during urination.The rationale of this study is to evaluate the clinical efficacy and safety of vaginal probiotic capsule (LABTHERA-001) in Bacterial Vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Non-pregnant, non-breastfeeding females between the ages of 20 and 45 years, inclusive willing to participate in study and provide written informed consent.
- •Women of childbearing potential must agree to practice reliable contraception for the 28-day period before enrollment through 30 days following treatment.
- •Agree to abstain from sexual intercourse 24 hours before each visit and 6 hours after IP insertion and agrees to follow medically acceptable method of contraception.
- •Presenting with signs of Bacterial Vaginosis (as per Amsel Criteria).
- •Vaginal specimen should have a Nugent score of greater than or equal to 4
- •Women who are currently not menstruating or expected not to have menstruation within 17 days from screening
- •Able to understand and comply with planned study procedures
- •Willing to abstain from insertion of tampons, douches, or other intravaginal medications or objects during study
- •Negative serum or urine pregnancy test
- •Provide written informed consent before initiation of any study procedures and be available for all study visits
- •No known history of HIV
- •Have a refrigerator to store the investigational product.
排除标准
- •Potential participants who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study 2)Patients with vaginal, vulvar, or genitourinary condition that, according to the Investigators 14)Any other condition that in the opinion of the investigator does not justify the patient’s participation in the study judgement, may confound the interpretation of clinical response based on Liquid Based Cytology 3)Patients with a history of regional enteritis, ulcerative colitis, or a history of C.
- •difficile associated diarrhea 4)Patients with known current drug or alcohol abuse that could impact study compliance 5)Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis based on Liquid Based Cytology 6)Self-reported abnormal Papanicolaou smear (grade 3 or more) in the preceding 12 months 7)History of diabetes mellitus 8)Immunocompromised patients, including those with human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex as per HIV test 9)Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment 10)Terminally ill patients or patients with severe cardiac (creatine kinase values >3 X upper limit of normal laboratory values), hepatic (AST, ALT values >3 X upper limit of normal laboratory values) renal (creatinine > 2mg/dl) or history of cerebrovascular disease, malignancy, chronic uncontrolled systemic disease e.g., hypertension, collagen disorders, etc.
- •or any other serious medical illness.
- •Patients with known sensitivity to any of the active or inactive ingredients in the study drug 12)Patients with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the patient inappropriate for entry into the trial.
- •Patients who have participated in a new drug study in the past 3 months.
结局指标
主要结局
1. Reduction in Amsel Criteria
时间窗: 1. Visit 1,2,3,4,5,6 and 7 | 2. Visit 1,2,3,4,5,6 and 7 | 3. Visit 1,2,3,4,5,6 and 7 | 4. Visit 1,2,3,4,5,6 and 7
2. Reduction in Nugent Score
时间窗: 1. Visit 1,2,3,4,5,6 and 7 | 2. Visit 1,2,3,4,5,6 and 7 | 3. Visit 1,2,3,4,5,6 and 7 | 4. Visit 1,2,3,4,5,6 and 7
3. Microbiome restoration through vaginal specimen
时间窗: 1. Visit 1,2,3,4,5,6 and 7 | 2. Visit 1,2,3,4,5,6 and 7 | 3. Visit 1,2,3,4,5,6 and 7 | 4. Visit 1,2,3,4,5,6 and 7
4. LABTHERA-001 colonization through qPCR
时间窗: 1. Visit 1,2,3,4,5,6 and 7 | 2. Visit 1,2,3,4,5,6 and 7 | 3. Visit 1,2,3,4,5,6 and 7 | 4. Visit 1,2,3,4,5,6 and 7
次要结局
- Acceptability of treatment(a. Proportion of participants who comply with the)
- Tolerability of treatment:Tolerability will be assessed by proportion of participants(who discontinue investigational product early in each)
- Improvement in self-reported vaginal signs and symptoms(will be assessed for vaginal itch, vaginal burning, itch of)
- Number of positive Bacterial Vaginosis(Visit 1,2,3,4,5,6 and 7)
- Number of negative Bacterial vaginosis(Visit 1,2,3,4,5,6 and 7)
研究者
研究点 (3)
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