Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women

Wecare Probiotics

Status: Not yet enrolling

Conditions: Patients With Bacterial Vaginosis

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06821789

WK2025004

Details and patient eligibility

About

In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota 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 old, sexual activity, premenopausal women;
2. Nugent score for diagnosing BV ≥7;
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 disease or psychiatric illness;
3. Planning pregnancy, breastfeeding, menstruation;
4. within 5 days of the onset of the disease, any antibiotics have been used;
5. long-term use of contraceptives or immunosuppressants;
6. Allergic constitution or hypersensitivity 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 LRa05 (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