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

Abstract

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.

Role of probiotics in managing various human diseases, from oral pathology to cancer and gastrointestinal diseases

“…The consequent analyses confirmed the increment of L. plantarum, concomitant with inhibiting harmful bacteria such as Mobiluncus spp., Gardnerella vaginalis, and Atopobium vaginae. This clinical trial demonstrated that this probiotic complex can be used for treating BV, as it improves the vaginal microbiota (Park et al, 2023).…”

Beneficial effects of the probiotics and synbiotics supplementation on anthropometric indices and body composition in adults: A systematic review and meta‐analysis

“…The general characteristics of the included studies are outlined in Table S4. Trials were published between 1996 and 2023, and were carried out in Asia, 12,27–31,77–81,84–229 Europe, 230–262 America,…”

“…In total, 12,603 participants (6507 case subjects and 6096 control subjects) with ages ranged from 18 to 82 years and baseline BMI ranged between 19.1 and 38.76 kg/m 2 . Twenty‐six studies investigated the effects of probiotics and/or synbiotics in healthy subjects, 111,118,141,144,146,148,155,161,171,180,191,192,195,200,201,207,219,232,235,237,240,241,247,260,265,272 and the remaining studies enrolled unhealthy participants. All the studies were performed in both genders, whereas seven studies conducted on males 192,224,229,239,260,265,272 and 30 studies were on females 12,27,85,103,105,120,129,133,158,161,162,188,191,197,203,206,210,216,218,221,222,227,235,237,248,254,256,259,262,264 .…”

“…All the studies were performed in both genders, whereas seven studies conducted on males 192,224,229,239,260,265,272 and 30 studies were on females. 12,27,85,103,105,120,129,133,158,161,162,188,191,197,203,206,210,216,218,221,222,227,235,237,248,254,256,259,262,264 Follow-up length of the studies varied from 2 to 56 weeks. Among included studies, 50 RCTs administered synbiotics 27,30,77,84,89,91,93,94,97,100,[102][103][104]107,108,119,120,126,…”

Does “all disease begin in the gut”? The gut-organ cross talk in the microbiome

“…When considering probiotic interventions for vaginal health, it is essential to select probiotic strains with proven efficacy and safety profiles Lactobacillus (Lacticaseibacillus rhamnosus MG4288, Lactiplantibacillus plantarum MG989, Lacticaseibacillus paracasei MG4272, Ligilactobacillus salivarius MG242, and Limosilactobacillus fermentum MG901 species are the most used probiotics for vaginal health (Park et al 2023).…”