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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
17 Sep 2024
Historique:
received: 29 04 2024
accepted: 02 09 2024
medline: 18 9 2024
pubmed: 18 9 2024
entrez: 17 9 2024
Statut: epublish

Résumé

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. 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 8 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. ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.

Sections du résumé

BACKGROUND 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 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 8
DISCUSSION CONCLUSIONS
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.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.

Identifiants

pubmed: 39289685
doi: 10.1186/s13063-024-08444-8
pii: 10.1186/s13063-024-08444-8
doi:

Banques de données

ClinicalTrials.gov
['NCT05966649']

Types de publication

Journal Article Clinical Trial Protocol

Langues

eng

Sous-ensembles de citation

IM

Pagination

615

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Katrien Nulens (K)

Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium. katrien_nulens@hotmail.com.
Department of Development and Regeneration, KULeuven, Cluster Woman and Child, Leuven, Belgium. katrien_nulens@hotmail.com.

Els Papy (E)

Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.

Katrien Tartaglia (K)

Clinical Trial Unit, Ziekenhuis Oost-Limburg, Genk, Belgium.

Isabelle Dehaene (I)

Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium.

Hilde Logghe (H)

Department of Obstetrics and Gynaecology, AZ Sint-Lucas, Bruges, Belgium.
Department of Obstetrics and Gynaecology, AZ Sint-Jan, Bruges, Belgium.

Joachim Van Keirsbilck (J)

Department of Obstetrics and Gynaecology, AZ Sint-Jan, Bruges, Belgium.

Frédéric Chantraine (F)

Department of Obstetrics and Gynaecology, Hopital Citadelle, CHU Liège, Liège, Belgium.

Veronique Masson (V)

Department of Obstetrics and Gynaecology, Hopital Citadelle, CHU Liège, Liège, Belgium.

Eva Simoens (E)

Department of Obstetrics and Gynaecology, AZ Groeninge, Kortrijk, Belgium.

Willem Gysemans (W)

Department of Paediatrics and Neonatal Intensive Care Unit, Ziekenhuis Oost-Limburg, Genk, Belgium.

Liesbeth Bruckers (L)

Data Science Institute, I-Biostat, Hasselt University, Diepenbeek, Belgium.

Sarah Lebeer (S)

Department of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.

Camille Nina Allonsius (CN)

Department of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.

Eline Oerlemans (E)

Department of Bioscience Engineering, Research Group Applied Microbiology and Biotechnology, University of Antwerp, Antwerp, Belgium.

Deborah Steensels (D)

Department of Microbiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium.

Marijke Reynders (M)

Department of Microbiology, AZ Sint-Jan, Bruges, Belgium.

Dirk Timmerman (D)

Department of Development and Regeneration, KULeuven, Cluster Woman and Child, Leuven, Belgium.
Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

Roland Devlieger (R)

Department of Development and Regeneration, KULeuven, Cluster Woman and Child, Leuven, Belgium.
Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

Caroline Van Holsbeke (C)

Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.
Department of Obstetrics and Gynaecology, AZ Sint-Lucas, Bruges, Belgium.
Department of Obstetrics and Gynaecology, AZ Sint-Jan, Bruges, Belgium.

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