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Study identifier: NCT05966649 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Synbiotics in Patients at RIsk fOr Preterm Birth

Condition: Preterm Spontaneous Labor With Preterm Delivery · Preterm Birth · Microbial Colonization  ·  Sponsor: Ziekenhuis Oost-Limburg

PhaseNA
Planned participants402
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersYes

About this study

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. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye 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 (before 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. Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation). 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 are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maint…

This description comes directly from the study's public registry record.

Talk to the study team

Caroline Van Holsbeke, PhD  ·  003289804057  ·  Caroline.van.holsbeke@zol.be

Katrien Nulens, MD  ·  003289804125  ·  Katrien_Nulens@hotmail.com

Always discuss trial participation with your own doctor first.

Locations (9)

Universitaire Ziekenhuis AntwerpenEdegem, Antwerpen, BelgiumRecruiting
Ziekenhuis Oost-LimburgGenk, Limburg, BelgiumRecruiting
Universitaire Ziekenhuizen LeuvenLeuven, Limburg, BelgiumRecruiting
CHR CitadelleLiège, Liège, BelgiumRecruiting
UZ GentGhent, Oost-Vlaanderen, BelgiumRecruiting
AZ Sint-JanBruges, West-Vlaanderen, BelgiumRecruiting
AZ Sint-LucasBruges, West-Vlaanderen, BelgiumRecruiting
AZ Maria MiddelaresGhent, West-Vlaanderen, BelgiumRecruiting
AZ GroeningeKortrijk, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT05966649