Health Condition 1: N760- Acute vaginitis
Conditions
Interventions
Intervention1: Lactobacillus gasseri KABP 064: Lactobacillus gasseri KABP 064 in delayed-released (DR)-capsules. Strength: 1 x 109 CFU/capsule
Control Intervention1: Placebo: Maltodextrin 346 mg/capsu
Sponsors
Kaneka Americas Holding
Eligibility
Inclusion criteria
Inclusion criteria: 1) Females aged 18-45 years (both values included) who are premenopausal. 2) History of recurrent BV (at least 3 episodes in the last 12 months with at least one of them documented in the last 6 months). 3) Positive Amsels criteria (confirming active BV) determined by at least 3 out of the following 4 symptoms or signs: - Homogeneous, thin, yellowish-white/greyish-white discharge that smoothly coats the vaginal walls. - Presence of the clue cells on microscopic examination (as assessed by wet mount test). - A fishy odor of vaginal discharge after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as whiff test. - Vaginal pH greater than 4.5 4) Imbalance in vaginal pH (pH greater than 4.5). 5) Participants with Body Mass Index (BMI) 18.5-32.0 kg/m2. 6) Non-smokers. 7) Participants able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood and urine sample collection procedures and study visit schedule). 8) Participants who are literate enough to understand the essence of study are informed about the purpose of the study and understand their rights. 9) Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.
Exclusion criteria
Exclusion criteria: 1) Participants currently taking contraceptives and/or sexual hormones. 2) Pregnant or breastfeeding. 3) Menstrual period expected within the next 6 days of screening. 4) Irregular cycle (irregular (e.g., less than 21 or more than 35 days consistently, or cycle variability more than 4 days month-to-month). 5) Participants who have documented resistance to metronidazole. 6) Participants diagnosed with any vaginal or urinary tract infection other than BV. 7) Participants who have used other probiotics or antibiotics (vaginal, oral, parenteral) in the last 15 days. 8) Participants using other vaginal products with bacteriostatic or bactericide activity (such as lactic acid gels, herbal extracts, dequalinum chloride, etc.). 9) Participants with an intrauterine contraceptive device (IUCD/IUD) in situ at screening. 10) Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system. 11) Women diagnosed with Sexually transmitted infections (STIs) or Human immunodeficiency virus (HIV) infection. 12) Participants diagnosed with Polycystic ovary syndrome (PCOS) or other such diseases that further affect the hormonal homeostasis in women. 13) Presence of uncontrolled diabetes mellitus (Indicated by Fasting Blood Glucose (FBG) greater than or equal to 126 mg/dL. Fasting is defined as no caloric intake for at least 8 hours). 14) Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) greater than or equal to 140 mm Hg and/or Diastolic Blood Pressure (DBP) more than or equal to 90 mm Hg). 15) Untreated previously diagnosed thyroid disorders. 16) Participants who have a history of any significant neurological and psychiatric condition which may affect the participation and inference of the studys end points. 17) Participation in other clinical trials in last 3 months prior to screening. 18) Participants with substance abuse problems defined as: - High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any Day or 8 or more alcohol containing beverages per week for women. 19) Participants who have any of the following clinically significant illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, chronic gastrointestinal diseases, etc. 20) Any condition that could, in the opinion of the Investigator, preclude the participants ability to successfully and safely complete the study or that may confound study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Lactobacillus gasseri KABP 064 in preventing recurrence of BV infections, diagnosed using Amsel criteria, over a period of approximately 6 months as compared to placebo.Timepoint: Day 0 to Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Analysis of Analysis of BV recurrences confirmed by Nugent score (greater than or equal to 7) throughout the 6-month period (Main secondary endpoint).Timepoint: Day 6 to Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Analysis of BV recurrences diagnosed using Amsel criteria (at least 3 of 4 positive) and Nugent score (greater than or equal to 7)Timepoint: Day 6 to Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Time to first BV recurrence as assessed per Amsel criteria (at least 3 of 4 positive) and/or Nugent score (greater than or equal to 7).Timepoint: Day 6, Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Proportion of participants experiencing 2 or more, and 3 or more BV recurrences during the study period.Timepoint: Day 6 to Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Percentage of participants receiving first-line or second-line SOC.Timepoint: Day 6 to Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Absolute difference in the duration of the SOC consumptionTimepoint: Day 6 to Day 180;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Reduction in severity of symptoms associated with BV infection (itching, vaginal discharge, and odor) as assessed by Visual Analogue Scale (VAS).Timepoint: Day 0, Day 6, Day 22, Day 90, Day 180 and at recurrence visits;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Change in Duration (in days) of vaginal symptoms as assessed by VAS (including recurrence-related symptoms).Timepoint: Day 0, Day 6, Day 22, Day 90, Day 180 and at recurrence visits;To evaluate the efficacy of Lactobacillus gasseri KABP 064 as compared to placebo on Percentage of participan | — |
Countries
India
Contacts
Public ContactDr Shubhangi Mote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed