Health Condition 1: A499- Bacterial infection, unspecified
Conditions
Interventions
Intervention1: LactoSpore® Capsule containing 2 billion CFU of B. coagulans MTCC 5856.: Once a day for 28 days.
Control Intervention1: Placebo: Maltodextrin Capsule containing 175 mg: Once a day for 2
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients with reproductive potential aged more than 18 years to less than 45years. 2. Patients with signs & symptoms of Bacterial Vaginosis confirmed by Amsel Score >3. a) Thin, homogenous, or milky vaginal discharge b) Vaginal pH greater than 4.5 (i.e., greater than normal) c) Positive whiff test (fishy amine odor when 10 percent potassium hydroxide solution is added) d) Presence of > 20% per HPF of "Clue cells" on wet mount examination. 3. Confirmed case of BV with a Nugent Score above 3. 4. Participants with FBS 5. Participants with FBS 6. Participants with HbA1c 7. Ability to swallow and retain oral medications as per the protocol. 8. Participants should be willing to give written informed consent. 9. Participants should be willing to comply with requirements of the trial/ study.
Exclusion criteria
Exclusion criteria: 1. Possible allergic symptoms related to the study’s test supplements. 2. Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study. 3. Participants who are in menopausal transition / menopause. 4. Less than 6 weeks since the last delivery or abortion. 5. Mixed vaginal infection including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis. 6. Participants who are using vaginal medication, vaginal contraceptives or douches within 48 hours prior to the test. 7. Participants who are having sexual intercourse within 24 hours prior to the test. 8. Patients having sexually transmitted diseases and unhealthy cervix. 9. Participants with history of PCOD and Hysterectomy. 10. Individuals on special diet, gastric diseases, those taking additional vitamins, minerals, supplements & new contraceptive pills. 11. Recent use of any systemic or local antibiotics or probiotics in the past one month. 12. Patients with a diagnostic history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, valvular heart disease) hematological, hepatic, renal, respiratory, malignancy or genitourinary abnormalities or diseases or systemic diseases like hypertension, diabetes, or any clinical condition, according to the investigator which does not allow safe fulfilment of the study protocol. 13. History of chronic smoking and Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol). 14. Those who have participated in another clinical trial within the past 1 month of screening visit (visit 1) or those who plan to participate in any other study during the clinical trial period. 15. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion. 16. Any planned surgery during the study period. 17. Any other reason(s) as per principal investigator discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of LactoSpore® as an adjuvant in the treatment of Bacterial Vaginosis. 1. Reduction in Amsel Score & Nugent score from initial visit to final visit. 2. Change in percentage of “clue cells’’ from initial visit to final visit.Timepoint: 1. Day 0 to Day 28. 2. Day 0 to Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| •To assess the safety of LactoSpore® as an adjuvant in the treatment of Bacterial Vaginosis. • To assess the change in the composition of Vaginal Microbiota (VM) by Nugent Scoring and Quality of Life by Quality of Life Questionnaires (SF-36) at the end of the study. 1. Reduction in Nugent Score 2. Mean change in ESR 3. Mean change in Quality of Life [(SF-36) Questionnaires] 4. Safety determination based on the tolerance to LactoSpore® without any incidence of adverse eventsTimepoint: 1. Day 0 to Day 28 2. Screening day (-2) to Day 28. 3. Day 0 to Day 28. 4. Screening Day (-2) to Day 28. | — |
Countries
India
Contacts
Public ContactSatish G
Sami-Sabinsa Group limited
Outcome results
None listed