VaginitisNCT07882134
Oral Multi-Strain Lactobacillus Probiotic for Women With Vaginal Dysbiosis
A study testing Low-dose multi-strain Lactobacillus capsule and High-dose capsule in people with Vaginitis and Dysbiosis, run by Soon Chun Hyang University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Vaginitis, Dysbiosis, Vaginal Diseases
- What is being tested?
- Low-dose multi-strain Lactobacillus capsule and High-dose capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 19 to under 50 years
- Nugent score of 4 to 6 at screening
- Not menstruating on the day of the screening visit
- Willing to take part and gave written informed consent
Who cannot join
- Known allergy or hypersensitivity to the study product or its ingredients
- Used probiotics, prebiotics, postbiotics, or other vaginal-health supplements in the 4 weeks before screening
- Used vaginal tablets, gels, or other products inside the vagina for vaginal health in the 4 weeks before screening
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unwilling to use barrier contraception or avoid sex before study visits as required
- Using hormonal or chemical birth control
Show all 16Show fewer
- Irregular menstrual cycles
- Sexually transmitted infection or other vaginal infection
- Vaginal bleeding or abnormalities of the urinary or genital tract
- Pap smear showing high-grade squamous intraepithelial lesion or worse
- Visible inflammation of the vulva
- Used antibiotics, antimicrobials, steroids, or immune-suppressing drugs in the 2 weeks before screening
- Serious underlying disease, abnormal liver or kidney function, or uncontrolled high blood pressure or diabetes
- History of serious psychiatric disorder, or alcohol or drug abuse
- Took part in another clinical trial or used an investigational product in the month before screening
- Any other reason the investigator judged participation unsuitable
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
About this study
Official title: Clinical Effects of a Multi-Strain Microbiome-Based Oral Therapeutic in Women With Vaginal Dysbiosis
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.
Read the detailed description
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.
- Conditions
- Vaginitis, Dysbiosis, Vaginal Diseases
- Being tested
- Low-dose multi-strain Lactobacillus capsule, High-dose capsule, Placebo capsule
- Keywords
- vaginal dysbiosis, vaginal microbiome, oral probiotic, Lactobacillus, Nugent score
- Medical subject headings
- Vaginitis, Dysbiosis, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose multi-strain Lactobacillus capsuleDietary supplement
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.
High-dose capsuleDietary supplement
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.
Placebo capsuleDietary supplement
One capsule taken by mouth once a day for 12 weeks. It looks the same as the probiotic capsules but contains no probiotic bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose probiotic | Experimental | Participants take one low-dose probiotic capsule (about 1 billion CFU of three Lactobacillus strains) by mouth once a day for 12 weeks. Receives: Dietary Supplement: Low-dose multi-strain Lactobacillus capsule |
| High-dose probiotic | Active comparator | High-dose probiotic Receives: Dietary Supplement: High-dose capsule |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start28 May 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups ran side by side for 12 weeks: low-dose probiotic, high-dose probiotic, and placebo. Participants were assigned at random in a 1:1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, The Catholic University of Korea, Gangnam CHA Medical Center, CHA University, Yuhan Care Co., Ltd.
- Responsible party
- Principal investigator, Ho-Yeon Song, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882134
- Sponsor's protocol ID
- FF13-2J1
- Other IDs
- RS-2023-00219563, KC23HODE0109, GCI 2023-01-006
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a Multi-Strain Microbiome-Based Oral Therapeutic in Women With Vaginal Dysbiosis
- ClinicalTrials.gov ID
- NCT07882134
- Acronym / sponsor ID
- FF13-2J1
- Conditions
- Vaginitis, Dysbiosis, Vaginal Diseases
- Keywords
- vaginal dysbiosis, vaginal microbiome, oral probiotic, Lactobacillus, Nugent score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, The Catholic University of Korea, Gangnam CHA Medical Center, CHA University, Yuhan Care Co., Ltd.
- Study start
- 28 May 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three groups ran side by side for 12 weeks: low-dose probiotic, high-dose probiotic, and placebo. Participants were assigned at random in a 1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Low-dose probiotic | Experimental | Dietary Supplement: Low-dose multi-strain Lactobacillus capsuleParticipants take one low-dose probiotic capsule (about 1 billion CFU of three Lactobacillus strains) by mouth once a day for 12 weeks. |
| High-dose probiotic | Active comparator | Dietary Supplement: High-dose capsuleHigh-dose probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsulePlacebo |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 19 to under 50 years
- Nugent score of 4 to 6 at screening
- Not menstruating on the day of the screening visit
- Willing to take part and gave written informed consent
Key exclusion criteria (16 listed)
- Known allergy or hypersensitivity to the study product or its ingredients
- Used probiotics, prebiotics, postbiotics, or other vaginal-health supplements in the 4 weeks before screening
- Used vaginal tablets, gels, or other products inside the vagina for vaginal health in the 4 weeks before screening
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unwilling to use barrier contraception or avoid sex before study visits as required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose multi-strain Lactobacillus capsuleOne 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 | Low-dose probiotic |
| High-dose capsuleOne 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 | High-dose probiotic |
| Placebo capsuleOne capsule taken by mouth once a day for 12 weeks. It looks the same as the probiotic capsules but contains no probiotic bacteria. | Dietary supplement | Placebo |
Primary outcome
Change in Nugent score
Time frame: Baseline (week 0) and week 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose multi-strain Lactobacillus capsule and High-dose capsule in people with Vaginitis and Dysbiosis, run by Soon Chun Hyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nugent score (time frame: Baseline (week 0) and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.