Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754645
Status:
RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-01-24
Brief Title:
The Microbiome in Non- Obese Pregnancy and Pregnancy Outcomes
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The PROMOTE Study a Pilot The Characterization of the Microbiome in Pregnancy and Prediction of Pregnancy Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMOTE
Brief Summary:
This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring
Detailed Description:
With the increasing global prevalence of obesity pregnancy problems related to maternal obesity are increasingly occurring Microbial gut symbiosis plays an important role in health with dysbiosis being associated with diseases such as obesity Of interest are pregnancy dietary patterns and pre- or probiotics that affect the composition of the gut microbiome The microbiome itself can influence many physiological processes such as immune responses production of microbial products and the nutrient-dependent one-carbon metabolism It is hypothesized that gut dysbiosis due to maternal obesity during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism Both processes result in excessive oxidative stress detrimental to cell replication differentiation and epigenetic programming of maternal and infant tissues Together these biological disturbances contribute to placental and vascular dysfunction leading to an increased risk of preeclampsia or gestational diabetes mellitus Vertical during pregnancy and horizontal during delivery transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children Therefore the differences between the gut and vaginal microbiome maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None