PRIORI: Synbiotics in Patients at RIsk fOr preterm birth: a multi-center double-blind Randomized placebo-controlled trial (KCE-201273)

Summary (French or Dutch)

Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns’ life, prematurity can cause long-lasting health problems (e.g. developmental disorders, learning difficulties, hearing problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.

Previous preterm delivery (< 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as ‘high risk’ for preterm birth.

From previous research, we know that infections arising from the vagina may be an important cause of preterm delivery. Researchers have recently found that the vaginal flora is disturbed early in pregnancy in women who deliver prematurely. On the other hand, the vaginal flora is extremely stable and resistant to infections in healthy pregnant women who deliver at term.

Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy while prebiotics may promote the growth of the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. We will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. Our hypothesis is that synbiotics when started early in the pregnancy, can change the disturbed vaginal flora into a stable environment.