Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Open accessAbstract
Bacterial vaginosis (BV) is the most common disease in women of childbearing age and is caused by the growth of abnormal microbiota in the vagina. Probiotic consumption can be an effective alternative treatment to preserve or improve vaginal health. In the present study, MED-01, a complex of five strains of probiotic candidates isolated from the vagina of Korean women, was used. This study was designed as a 12-week, randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MED-01 on vaginal health. A total of 101 reproductive-aged women with a Nugent score of 4–6 took MED-01 (5.0 × 109 CFU) or a placebo once a day, and 76 participants completed the procedure. MED-01 significantly reduced the Nugent score compared with the placebo. Quantitative PCR analysis confirmed that Lactobacillus plantarum was significantly increased in the vagina, whereas harmful bacteria such as Mobiluncus spp., Gardnerella vaginalis, and Atopobium vaginae were suppressed after 12 weeks of MED-01 ingestion. No adverse events to the test food supplements were observed in the participants. These results confirmed that MED-01 can be used as a probiotic for treating BV, as it improves the vaginal microbiota.
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- Authors
- Park, S.-H., Lee, E. S., Park, S. T., Jeong, S. Y., Yun, Y., Kim, Y., Jeong, Y., Kang, C.-H., & Choi, H. J.
- Affiliations
- Hallym University Kangnam Sacred Heart Hospital (KR)
- Soonchunhyang University (KR)
- Mediogen, Co., Ltd., Biovalley 1-ro, Jecheon-si 27159, Chungcheongbuk-do, Republic of Korea
- Chung-Ang University Gwangmyeong Hospital (KR)
- Corresponding author
- Choi, Hyun Jin
- ORCID
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2023-01-09
- Volume
- 15
- Issue
- 2
- Pages
- 331
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC9863863
- OpenAlex
- W4315491746
- Cited by
- 22
- References
- 3
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 9 · 2023: 2
- FWCI
- 4.04
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Ministry of SMEs and Startups (MSS, Korea) (S2859861)
- Topics
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- bacterial vaginosis, probiotics, vaginal microbiota, Lactobacillus plantarum, Nugent score, Gardnerella vaginalis, Atopobium vaginae, Mobiluncus, probiotic supplementation, vaginal health, women of reproductive age
- MeSH terms
- Adult, Female, Gardnerella vaginalis, Humans, Vagina, Vaginosis, Bacterial, Dietary Supplements, Probiotics
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