Effect of Probiotic on Bacterial Vaginosis
- Conditions
- Health Condition 1: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
- Registration Number
- CTRI/2022/10/046723
- Lead Sponsor
- Atogen Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Non-pregnant, non-breastfeeding females between the ages of 20 and 45 years, inclusive willing to participate in study and provide written informed consent.
2. Women of childbearing potential must agree to practice reliable contraception for the 28-day period before enrollment through 30 days following treatment.
3. 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.
4. Presenting with signs of Bacterial Vaginosis (as per Amsel Criteria).
5. Vaginal specimen should have a Nugent score of greater than or equal to 4
6. Women who are currently not menstruating or expected not to have menstruation within 17 days from screening
7. Able to understand and comply with planned study procedures
8. Willing to abstain from insertion of tampons, douches, or other intravaginal medications or objects during study
9. Negative serum or urine pregnancy test
10. Provide written informed consent before initiation of any study procedures and be available for all study visits
11. No known history of HIV
12. Have a refrigerator to store the investigational product
1)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 patientâ??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.
11)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.
13)Patients who have participated in a new drug study in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reduction in Amsel Criteria <br/ ><br>2. Reduction in Nugent Score <br/ ><br>3. Microbiome restoration through vaginal specimen <br/ ><br>4. LABTHERA-001 colonization through qPCRTimepoint: 1. Visit 1,2,3,4,5,6 and 7 <br/ ><br>2. Visit 1,2,3,4,5,6 and 7 <br/ ><br>3. Visit 1,2,3,4,5,6 and 7 <br/ ><br>4. Visit 1,2,3,4,5,6 and 7
- Secondary Outcome Measures
Name Time Method