Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)

Nulens, Katrien; Papy, Els; Tartaglia, Katrien; Dehaene, Isabelle; Logghe, Hilde; Van Keirsbilck, Joachim; Chantraine, Frederic; Masson, Veronique; Simoens, Eva; Gysemans, Willem; Bruckers, Liesbeth; Lebeer, Sarah; Allonsius, Camille Nina; Oerlemans, Eline; Steensels, Deborah; Reynders, Marijke; Timmerman, Dirk; Devlieger, Roland; Van Holsbeke, Caroline

Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)

Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene (UGent) , Hilde Logghe, Joachim Van Keirsbilck, Frederic Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, et al.

(2024) TRIALS. 25(1).

Author

Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene (UGent) , Hilde Logghe, Joachim Van Keirsbilck, Frederic Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, Liesbeth Bruckers, Sarah Lebeer, Camille Nina Allonsius, Eline Oerlemans, Deborah Steensels, Marijke Reynders, Dirk Timmerman, Roland Devlieger and Caroline Van Holsbeke

Organization

Abstract

Background Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. Methods We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 80/7-106/7 weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 240/7-356/7 weeks, prior PPROM before 360/7 weeks, or spontaneous pregnancy loss at 140/7-236/7 weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. Discussion This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes.

Keywords

INTERNATIONAL SCIENTIFIC ASSOCIATION, BACTERIAL VAGINOSIS, CONSENSUS STATEMENT, LACTOBACILLUS, PROBIOTICS, RECURRENCE, PREBIOTICS, INFECTION, PREGNANCY, FLORA, Preterm birth, Prematurity, PPROM, Vaginal microbiome, Pregnancy, Probiotics, Synbiotics, Lactobacilli, Next-generation sequencing, Randomised controlled trial

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Citation

Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-01JPA3D6AC2A1AR4M6VWCKGWC2

MLA: Nulens, Katrien, et al. “Synbiotics in Patients at Risk for Spontaneous Preterm Birth : Protocol for a Multi-Centre, Double-Blind, Randomised Placebo-Controlled Trial (PRIORI).” TRIALS, vol. 25, no. 1, 2024, doi:10.1186/s13063-024-08444-8.
APA: Nulens, K., Papy, E., Tartaglia, K., Dehaene, I., Logghe, H., Van Keirsbilck, J., … Van Holsbeke, C. (2024). Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI). TRIALS, 25(1). https://doi.org/10.1186/s13063-024-08444-8
Chicago author-date: Nulens, Katrien, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frederic Chantraine, et al. 2024. “Synbiotics in Patients at Risk for Spontaneous Preterm Birth : Protocol for a Multi-Centre, Double-Blind, Randomised Placebo-Controlled Trial (PRIORI).” TRIALS 25 (1). https://doi.org/10.1186/s13063-024-08444-8.
Chicago author-date (all authors): Nulens, Katrien, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frederic Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, Liesbeth Bruckers, Sarah Lebeer, Camille Nina Allonsius, Eline Oerlemans, Deborah Steensels, Marijke Reynders, Dirk Timmerman, Roland Devlieger, and Caroline Van Holsbeke. 2024. “Synbiotics in Patients at Risk for Spontaneous Preterm Birth : Protocol for a Multi-Centre, Double-Blind, Randomised Placebo-Controlled Trial (PRIORI).” TRIALS 25 (1). doi:10.1186/s13063-024-08444-8.
Vancouver: 1.
Nulens K, Papy E, Tartaglia K, Dehaene I, Logghe H, Van Keirsbilck J, et al. Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI). TRIALS. 2024;25(1).
IEEE: [1]
K. Nulens et al., “Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI),” TRIALS, vol. 25, no. 1, 2024.

@article{01JPA3D6AC2A1AR4M6VWCKGWC2,
  abstract     = {{Background Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. Methods We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 80/7-106/7 weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 240/7-356/7 weeks, prior PPROM before 360/7 weeks, or spontaneous pregnancy loss at 140/7-236/7 weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. Discussion This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes.}},
  articleno    = {{615}},
  author       = {{Nulens, Katrien and Papy, Els and Tartaglia, Katrien and Dehaene, Isabelle and Logghe, Hilde and Van Keirsbilck, Joachim and Chantraine, Frederic and Masson, Veronique and Simoens, Eva and Gysemans, Willem and Bruckers, Liesbeth and Lebeer, Sarah and Allonsius, Camille Nina and Oerlemans, Eline and Steensels, Deborah and Reynders, Marijke and Timmerman, Dirk and Devlieger, Roland and Van Holsbeke, Caroline}},
  issn         = {{1745-6215}},
  journal      = {{TRIALS}},
  keywords     = {{INTERNATIONAL SCIENTIFIC ASSOCIATION,BACTERIAL VAGINOSIS,CONSENSUS STATEMENT,LACTOBACILLUS,PROBIOTICS,RECURRENCE,PREBIOTICS,INFECTION,PREGNANCY,FLORA,Preterm birth,Prematurity,PPROM,Vaginal microbiome,Pregnancy,Probiotics,Synbiotics,Lactobacilli,Next-generation sequencing,Randomised controlled trial}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{14}},
  title        = {{Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)}},
  url          = {{http://doi.org/10.1186/s13063-024-08444-8}},
  volume       = {{25}},
  year         = {{2024}},
}

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Synbiotics in patients at risk for spontaneous preterm birth : protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)

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