P-552 Pilot study to determine efficacy of L. rhamnosus BPL205, L. plantarum BPL207 and L.crispatus BPL209 in normalizing the vaginal environment (study PROSALVAG)
Authors: González E , Paisano Y , Ramos M I 
Published: June 2023

Abstract

Study question
Can the use of orally L.rhamnosus PBL205, L. plantarum BPL207 and L.crispatus BPL209 reestablish the vaginal environment?

Summary answer
The use of oral probiotics changes the infectious microbiological vaginal environment to a healthy one, consequently the vaginal pH is reestablished.

What is known already
The normal flora of the reproductive tract includes a variety of Lactobacillus species that promote a healthy environment for the embryo during the preimplantation period, so that Lactobacillus spp. are considered to promote ideal environment for implantation. Live birth rate correlates directly with the presence of Lactobacillus and inversely with the existence of bacterial vaginosis.
Alterations of the vaginal flora such as bacterial vaginosis are related to an increased risk of miscarriage. It has been shown that women with an unbalanced vaginal microbiome are 1.4 times less likely to achieve pregnancy after IVF treatment compared to women with normal microbiome.

Study design, size, duration
Prospective pilot study to assess the effect of 10 weeks of use of an oral probiotic containing Lactobacillus rhamnosus BPL205, Lactobacilus plantarum BPL 207 and Lactobacillus crispatus BPL209 supplemented with vitamin D, in vaginal health reestablishment. 21 women assisting to a fertility clinic and with indication of vaginal microbiota restoration and low number of vaginal Lactobacillus were recruited. After 5 and 10 weeks of supplementation, the reestablishment of vaginal health was study.

Participants/materials, setting, methods
Women with indication of vaginal microbiota restoration, low number of vaginal Lactobacillus and with the informed consent signed, were asked to take a nutraceutical with probiotic and vitamin D once a day for 10 weeks. Cytology, vaginal pH and pain were analyzed at 5 and 10 weeks. In those patients with some kind of infection diagnosed the levels of TNF-α was analyzed after 5 weeks of probiotic use.

Main results and the role of chance
All patients started the study with vaginal pH &gt; 4,5. After the use of oral probiotic containing Lactobacillus rhamnosus BPL205, Lactobacilus plantarum BPL 207 and Lactobacillus crispatus BPL209 supplemented with vitamin D (oral probiotic) during 5 weeks, 66,7% of the patients obtained a pH &lt; 4,5. After the use of oral probiotic during 10 weeks all patients achieve a pH &lt; 4,5.
At the beginning of the study all patients result in yeast or vaginosis profile in their cytology, in except one. After 5 weeks with oral probiotic, 73,7% of them turns into a healthy vaginal flora essential to control pathogen proliferation (Döderlein flora: more of two hundred species with Lactobacillus predominance). After 10 weeks this percentage increase to 89,5%.
There is a statistically significant reduction in Menstrual pain from an intensity of 6,1± 1,8 (mean ± standard deviation) to an intensity of 3,8 ± 3,5 at week 5 and to a 1,5 ± 3,0 at week 10 (p = 0,01 and P &lt; 0,0001 respectively).
In patients diagnosed with chronic endometritis at the beginning of the study (n = 5) TNF-α levels decrease from 8,14 ± 1,8 to 5,59 ± 2,3 after 10 weeks using the oral probiotic in study (p = 0,02).

Limitations, reasons for caution
The main limitation was the number of patients recluted. We have present the preliminary results of a study that continue recruiting patients in order to diminish the limitation of the study. Also, the number of parameters studied is being increased

Wider implications of the findings
The use of L.rhamnosus PBL205, L. plantarum BPL207 and L.crispatus BPL209 reestablish the healthy vaginal environment of women with an unhealthy ones. This allows better environmen for fertility and t to control pathogen proliferation. An improvement in inflammatory conditions in that patients with chronic endometritis is also observed.

Trial registration number
Not applicable