The first clinical study of SynForU-HerCare has found that the probiotic is effective in reducing vulvovaginal symptoms and recurrences of vaginal candidiasis (VC) in pregnant women, with researchers noting that this could be a potential strategy for vaginal health maintenance during pregnancy.
The research, published in the Journal of Applied Microbiology, highlighted the preventive and modulatory roles of lactobacilli strains against VC in pregnant women.
The strains
The probiotic blend is isolated from dairy, namely Lactobacillus plantarum LP115, Lactobacillus helveticus LA25, Lactobacillus rhamnosus LRH10, Lactobacillus paracasei LPC12, Lactobacillus fermentum LF26, and Lactobacillus delbrueckii subspecies lactis LDL114.
“These strains were selected because in vitro study, it was found that these strains are superior in adhesive ability to Hela cell, hydrogen peroxide production to inhibit infectious urogenital bacteria such as Salmonella, Escherichia coli, C. albicans, and Gardnerella vaginalis, and antibacterial activity compared to other intimate care probiotics in the market. These strains have also been tested to ensure its quality, efficacy and performance,” explained Lisa Chen, Marketing Manager of SynbioTech.
The study
Seventy-eight subjects at 14-32 weeks of pregnancy with VC, completed the double-blind, placebo-controlled randomized 8-week study. The intervention group took lactobacilli probiotics for 8 weeks.
The lactobacilli group showed a 45% reduction of vulvovaginal symptoms such as irritation, discharge and burning, 31% reduction of worry, 34.6% reduction of the impairment of daily activities attributed to VC at week-8, whereas the placebo group showed no significant changes in emotional stress or in social impacts. The lactobacilli group also reported a 38% decrease in recurrences of emotional stress at week-8 and marginally reduced constipation.
The results indicate that supplementation of SynForU-HerCare reduces vulvovaginal symptoms, recurrences of VC, and improves emotional and social distress attributed to VC.
The pregnant population
The research also highlighted the importance of researching this often overlooked population.
“In terms of inclusivity in clinical research, pregnant women are indeed a left behind group. There is still a knowledge gap in research of the pregnant population,” said Chen. “Indeed, researching pregnant subjects does come up with challenges such as recruitment and retention hurdles, as well as lack of healthy volunteers. Additionally, due to the sensitive nature of the pregnancy, there is a high concern for safety not only for the pregnant woman but also for the growing fetus. However, despite all the challenges, the researchers prioritized inclusion of pregnant subjects in this study because there is an even higher prevalence of vaginal yeast infections in this population.”
Chen added that this research studying the use of lactobacilli probiotics in pregnant subjects is impactful because it is the first study to provide clinical evidence on the impact of lactobacilli strains in improving quality of life in pregnant women with VC.
The challenges of recruiting pregnant women
Pregnant women have historically been excluded from clinical trial research, given their former “vulnerable population” status and in consideration of potential impacts to the developing fetus. While challenging, it is crucial to enlist a diverse sample of pregnant women for clinical research to improve maternal and child health outcomes.
According to a 2020 study published in Ochsner Journal, "research in pregnant women has been hampered by concerns for liability, the complex physiology of pregnancy with changes related to stage of pregnancy, and federal regulations that deemed pregnant women a vulnerable population. While recent revisions to federal regulations have removed pregnant women from the classification of vulnerable population, regulations regarding consent requirements still limit women's ability to decide on participation in clinical trials. The Department of Health and Human Services established the Task Force on Research Specific to Pregnant Women and Lactating Women to help identify and reduce these barriers."
“Recruitment challenges are not impossible to overcome. Engagement of healthcare providers is a critical component for recruitment because participants are more likely to sign up for research if it has been recommended by their healthcare provider," said Chen. "We were grateful to be able to collaborate with Hospital USM in Kubang Kerian, and health clinics in Kelantan, Malaysia to make the recruitment successful."
Benefits go beyond pregnant women
“Health of a pregnant woman not only affects the woman, but also the child. In order for a woman to give birth to a healthy child, mother’s health, both physical and mental health, are extremely crucial. Studies indicate that the first 1,000 days of a child's life, from the moment they are conceived until they have reached 2 years of age, are vital for their brain, body and immune system development. Therefore, improving the health of a pregnant woman also means improving the health of the child,” noted Chen.
Chen added that pregnant women are at higher risk for vaginal candida due to hormonal changes, vaginal glycogen production and certain immunologic alterations during pregnancy which may lead to an overgrowth of yeast.
“SynForU-HerCare is designed to reduce vaginal yeast infections in all women, both pregnant and non-pregnant. So, yes, it is effective for non-pregnant women with yeast infections as well,” Chen told NutraIngredients-USA.
Source: Journal of Applied Microbiology
22 May 2021 doi.org/10.1111/jam.15158
“Lactobacilli Reduce Recurrences of Vaginal Candidiasis in Pregnant Women: A Randomized, Double-Blind, Placebo-Controlled Study”
Authors: X. Ang et al.