In a study sponsored by Vesale Pharma, the team finds the oral intake of Lactogyn, a blend of L. crispatus LMG S-29995, L. brevis, and L. acidophilus, can also prolong time to recurrence of the disease.
“Our study showed that four-month oral use of lactobacilli, started immediately after a cure by antibiotic therapy, significantly decreased the number of recurrences of BV,” the study says.
“Previous studies differed by a smaller sample size (22–60 patients), a shorter-term (7–28 days) application of lactobacilli, variations in inclusion criteria or simultaneous initiation antibiotic therapy with lactobacilli.
“In all listed trials, benefits were achieved independently of the type of the protocol and included decrease in BV incidence, reduction of symptoms, and improvement of vaginal bacterial ecology.”
While the treatment of BV is usually a course of the antibiotic metronidazole, there remains no consensus on its prevention and reoccurrence.
Use of metronidazole is associated with 58% recurrence rate with approximately more than 40% of cases occurring during the first four months.
It has been shown that lactobacilli taken orally can improve vaginal bacterial ecology and decrease recurrence rate of BV in heterogeneous groups of women.
The rationale behind the oral use of lactobacilli has served as indirect evidence for the present understanding that colonic bacteria can translocate into the vagina.
Probiotic addition
“The idea is to combine the probiotic with the classic antibiotic treatment, which is considered very efficient and is easy to take,” explains Dr Karl Richir, study team member and medical director at Belgium-based Vesale Pharma.
“However, in Belgium, some physicians have decided to try the probiotic blend only, mostly in women with a long history of recurrent BV incidences."
Research into conditions such as BV is considered complicated due to the varied understanding of what constitutes a healthy vaginal microbiota made more complex by its ever-changing community within group types and even for individual women.
Another issue here is that once BV has occurred the window to understand its causality is missed leading to researchers to call for more prospective, longitudinal studies to be performed in order to better understand its nature.
“The majority of physicians and patients just want a solution to BV,” says Dr Richir. “I think with this kind of alternative treatment, we bring a solution to the recurrence problem.
“But this is a complex problem and is determined by the patient’s lifestyle, age, sexual status amongst other factors. So, I think once again, it is not possible to isolate one clear explanation because it is so different from woman to woman.
“You could argue that it is the same problem with the gut microbiota and how it differs from person to person or group of people.”
Study details
Along with colleagues from Zaporizhzhia State Medical University and Ivano-Frankivsk National Medical University in the Ukraine, the team began enrolling 166 women 18 to 45-years of age recently cured of BV by metronidazole.
Within 48 hours after completion of metronidazole therapy, eligible women received one capsule containing a combination of lactobacilli in a dose of 5.4 billion.
This probiotic blend contained L. crispatus LMG S-29995, Lactobacillus brevis, and Lactobacillus acidophilus in proportion of 60%, 20%, and 20%, respectively.
The group were asked to take this blend two times daily for the first seven days and one time daily for the next eight to 120 days continuously after meals.
The placebo group received a similar test dietary supplement (TDS) that contained maltodextrin without lactobacilli in the same manner.
On every visit, the investigator asked about symptoms of BV and performed a standard examination with any vaginal discharge noted.
Out of the 166 analysed in the treatment (82 patients) and the placebo group (82 patients) recurrence of BV was documented in 15 (18.3%) of 82 women in the treatment group and 27 (32.1%) of 82 in the placebo group.
The research team also found rates of survival without BV rates were higher in the group. Both treatment and placebo supplements were well tolerated.
Double daily dosing
In the study’s discussion, the team highlights that lactobacilli were provided in a total dose of approximately 686 billion, which was higher than the total dose in previous studies.
The team suggests that double daily dosing during the first week could potentially have helped faster restore vaginal colonisation, and the longer-lasting supplementation could have increased chance of colonisation. However, this effect was not specifically evaluated.
“The objective of the treatment and of this publication is to show that women taking this supplement results in less relapses and occurrences of BV,” Dr Richir says.
“You can say that if you increase the dosage it could be interesting for the colonisation but don’t forget that for the majority of women receiving the probiotic will not be symptomatic because they have already received the antibiotic treatment. The probiotic is just prevention.
“From a marketing or commercial point of view, you could say that the patient could start with a five-day regimen of two capsules per day. But from a medical point of view, I’m not sure it would change anything.”
The team also acknowledges the study’s limitations, pointing to the unknown benefits of long-term probiotic supplementation beyond four months,
Other limitations include the absence of microbiological end points describing evolution of the colonic and vaginal flora before and during follow-up visits.
Source: Journal of Lower Genital Tract Disease
Published online ahead of print: doi: 10.1097/LGT.0000000000000518
“Oral Intake of Lactobacilli Can Be Helpful in Symptomatic Bacterial Vaginosis.”
Authors: Reznichenko, Halyna et al.