An interventional study of Low-dose multi-strain Lactobacillus capsule and High-dose capsule in Vaginitis, Dysbiosis and Vaginal Diseases, sponsored by Soon Chun Hyang University. Completed at 1 site in South Korea. Open to female participants aged 19 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Soon Chun Hyang University · Not applicable, Interventional, and Treatment
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.
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial run at two hospitals in South Korea: Seoul St. Mary's Hospital (The Catholic University of Korea) and Gangnam CHA Medical Center (CHA University). The trial was sponsored by Yuhan Care Co., Ltd.
A total of 119 women were enrolled. Each was randomly assigned to the high-dose probiotic, the low-dose probiotic, or placebo group. The study product was taken orally once daily for 12 weeks.
Participants attended study visits at [list visit schedule, e.g. baseline and week 12, plus any interim visits]. At these visits, vaginal swabs were collected and scored using the Nugent method, vaginal pH was measured, and participants reported their symptoms. Vaginal samples were also analyzed by sequencing to track changes in bacterial community composition.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 119 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →Soon Chun Hyang University is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants take one low-dose probiotic capsule (about 1 billion CFU of three Lactobacillus strains) by mouth once a day for 12 weeks.
Dietary Supplement: Low-dose multi-strain Lactobacillus capsule
High-dose probiotic
Dietary Supplement: High-dose capsule
Placebo
Dietary Supplement: Placebo 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.
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.
One capsule taken by mouth once a day for 12 weeks. It looks the same as the probiotic capsules but contains no probiotic bacteria.
Change in Nugent score
Nugent score is a lab method that rates vaginal bacteria on a 0 to 10 scale from a stained vaginal swab. Higher scores mean fewer Lactobacillus and more harmful bacteria. The outcome is the change from baseline to week 12 in each group.
Time frame: Baseline (week 0) and week 12
Plan to share: No — Individual participant data will not be shared because the data are owned by the study sponsor and participant consent did not cover sharing of identifiable data. Summary results are reported in the published paper.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Soon Chun Hyang University