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Title: | Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI) | Authors: | 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 |
Issue Date: | 2024 | Publisher: | BMC | Source: | Trials, 25 (1) (Art N° 615) | 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. | Notes: | Nulens, K (corresponding author), Ziekenhuis Oost Limburg, Dept Obstet & Gynaecol, Genk, Belgium.; Nulens, K (corresponding author), Katholieke Univ Leuven, Dept Dev & Regenerat, Cluster Woman & Child, Leuven, Belgium. katrien_nulens@hotmail.com |
Keywords: | Preterm birth;Prematurity;PPROM;Vaginal microbiome;Pregnancy;Probiotics;Synbiotics;Lactobacilli;Next-generation sequencing;Randomised controlled trial | Document URI: | http://hdl.handle.net/1942/44432 | e-ISSN: | 1745-6215 | DOI: | 10.1186/s13063-024-08444-8 | ISI #: | 001314968100001 | Rights: | The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modifed the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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