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COMPLETED
NCT07882134
NA

Oral Multi-Strain Lactobacillus Probiotic for Women With Vaginal Dysbiosis

Sponsor: Soon Chun Hyang University

View on ClinicalTrials.gov

Summary

Many women have an imbalance in their vaginal bacteria that can cause discomfort, irritation, and repeat infections. In a healthy vagina, helpful Lactobacillus bacteria are the main group of microbes. When they decline, other bacteria such as Gardnerella can take over. Most probiotic treatments for this problem are applied vaginally, and many women find them inconvenient. This study tested a probiotic capsule taken by mouth. The capsule contained three Lactobacillus strains, taken from vaginal bacteria and from fermented foods. The study enrolled women aged 19 to 49 whose vaginal bacteria were in a borderline, mildly unbalanced state. Participants were randomly placed in one of three groups: a high-dose probiotic, a low-dose probiotic, or a placebo. They took their assigned product once a day for 12 weeks. Neither participants nor study staff knew who received which product. The study looked at whether the probiotic improved the balance of vaginal bacteria, vaginal acidity, and symptoms, and whether it was safe to take.

Official title: Clinical Effects of a Multi-Strain Microbiome-Based Oral Therapeutic in Women With Vaginal Dysbiosis

Key Details

Gender

FEMALE

Age Range

19 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2023-05-28

Completion Date

2024-07-12

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Low-dose multi-strain Lactobacillus capsule

One capsule taken by mouth once a day for 12 weeks. Each capsule provides about 1 billion CFU (1 x 10\^9) of a mix of three Lactobacillus strains: L. crispatus, L. fermentum, and L. plantarum.

DIETARY_SUPPLEMENT

High-dose capsule

One capsule taken by mouth once a day for 12 weeks. Each capsule provides about 2 billion CFU (2 x 10\^9) of the same three Lactobacillus strains: L. crispatus, L. fermentum, and L. plantarum.

DIETARY_SUPPLEMENT

Placebo capsule

One capsule taken by mouth once a day for 12 weeks. It looks the same as the probiotic capsules but contains no probiotic bacteria.

Locations (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea