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Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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 st...

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Autores principales: Park, Sung-Ho, Lee, Eun Sil, Park, Sung Taek, Jeong, Soo Young, Yun, Yeoul, Kim, YongGyeong, Jeong, Yulah, Kang, Chang-Ho, Choi, Hyun Jin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9863863/
https://www.ncbi.nlm.nih.gov/pubmed/36678202
http://dx.doi.org/10.3390/nu15020331
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author Park, Sung-Ho
Lee, Eun Sil
Park, Sung Taek
Jeong, Soo Young
Yun, Yeoul
Kim, YongGyeong
Jeong, Yulah
Kang, Chang-Ho
Choi, Hyun Jin
author_facet Park, Sung-Ho
Lee, Eun Sil
Park, Sung Taek
Jeong, Soo Young
Yun, Yeoul
Kim, YongGyeong
Jeong, Yulah
Kang, Chang-Ho
Choi, Hyun Jin
author_sort Park, Sung-Ho
collection PubMed
description 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 × 10(9) 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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spelling pubmed-98638632023-01-22 Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Park, Sung-Ho Lee, Eun Sil Park, Sung Taek Jeong, Soo Young Yun, Yeoul Kim, YongGyeong Jeong, Yulah Kang, Chang-Ho Choi, Hyun Jin Nutrients Article 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 × 10(9) 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. MDPI 2023-01-09 /pmc/articles/PMC9863863/ /pubmed/36678202 http://dx.doi.org/10.3390/nu15020331 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Park, Sung-Ho
Lee, Eun Sil
Park, Sung Taek
Jeong, Soo Young
Yun, Yeoul
Kim, YongGyeong
Jeong, Yulah
Kang, Chang-Ho
Choi, Hyun Jin
Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_fullStr Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full_unstemmed Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_short Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_sort efficacy and safety of med-01 probiotics on vaginal health: a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9863863/
https://www.ncbi.nlm.nih.gov/pubmed/36678202
http://dx.doi.org/10.3390/nu15020331
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