Effects of Lactobacillus Crispatus LCr86 on Bacterial Vaginosis and Ovarian Function in Women

Wecare Probiotics

Status: Not yet enrolling

Conditions: Patients With Bacterial Vaginosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06830122

WK2025005

Details and patient eligibility

About

Lactobacillus crispatus LCr86 was selected as a test preparation to observe its clinical efficacy in an intervention trial of combined antibiotic treatment and evaluate its effect on the cure rate, recurrence rate and vaginal flora of patients with bacterial vaginitis.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 to 65 years of age, history of sexual activity, premenopausal women;
2. Nugent score ≥ 7 for diagnosis of BV;
3. Signed informed consent.

Exclusion criteria

1. Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection, or gonococcal vaginitis;
2. History of systemic organic or psychiatric disease;
3. Planned pregnancy, breastfeeding, or menstruation;
4. Have used any antibiotics within 5 days of disease onset;
5. Long-term use of contraceptives or immunosuppressants;
6. Hypersensitivity or allergy to known components of the study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LCr86 (before meals);

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Conventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals);

Treatment:

Dietary Supplement: Placebo