This clinical study is set up to evaluate the effect of an oral dietary supplement, more specifically an oral synbiotic, on the vaginal microbiome and on the gestational age.

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The vagina consists of an environment of (healthy) microbes (called 'the vaginal microbiome') and this acts as a barrier to ascending infections.

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A synbiotic is a combination of probiotics (“healthy” live bacteria) and prebiotics (substances to support the survival and effects of probiotic bacteria). Well-known examples of nutritional supplements to improve the intestinal flora that contain these live bacteria are Yakult and Actimel. The synbiotic used in this study is not available on the market and consists of research-based, selected ingredients.

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The effect will be evaluated in a population of pregnant women who are at increased risk for spontaneous preterm birth. Premature birth has many possible causes and risk factors. In most cases plays infection an important role even without obvious clinical signs/symptoms of infection (such as fever). Previous studies have shown that most infections likely originate in the vagina, then ascend to the uterus, eventually infecting the membranes, placenta, and baby. Research has shown that, in women at increased risk of preterm birth, the vaginal microbiome can become unstable, putting them at greater risk of ascending infections.

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This study aims to investigate whether this particular oral synbiotic, when started early and taken throughout pregnancy, will have a beneficial effect on the vaginal microbiome, potentially extending gestational age.