Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-10 @ 12:00 AM
Study NCT ID:
NCT03116568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2017-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial Transmission In Utero and IBD Risk
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
A Prospective Study of Pregnant Women With and Without IBD in Order to Better Understand the Patterns of Bacterial Transmission From the Mother to the Baby (Bacterial Transmission In Utero and IBD Risk)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
None
Brief Summary:
Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.
Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us to understand the change of bacterial composition human microbiome in the gut during pregnancy and childhood development.
Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us to understand the change of bacterial composition human microbiome in the gut during pregnancy and childhood development.
Detailed Description:
Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.
Human microbiome studies have demonstrated dynamic changes in bacterial composition in the gut during pregnancy and childhood development. Moreover, the presence of pathogenic species, or absence of beneficial species, in early childhood has been suggested to play a key role in the initiation of preterm birth, development of asthma or eczema, allergy, autism or other immunological deficiency. The goal of this study is to better understand the link between maternal and newborn microbiome. Specifically, we will investigate the microbial composition of the stool of newborn babies born to mothers with certain health issues as compared to healthy mothers. This information may help identify the factors that can help better understand the risk transmitted through the microbiome.
By collecting the samples including stools, saliva and understanding the health history of pregnant women with or without Inflammatory bowel disease (IBD), we can compare the data of two groups pregnant women in order to find out the differences of microbiome in their guts. Another aim of our study is finding out the possibility of vertical bacteria transmission from mother to baby.
Furthermore, our main focus is the meconium of newborn baby, we would like to know that the differences of microbiome in the gut between the newborns from two groups. Therefore, we will collect the umbilical cord blood, placenta, amniotic membrane, newborn cheek swab, and meconium. To investigate the disease transmission rate from mothers.
Human microbiome studies have demonstrated dynamic changes in bacterial composition in the gut during pregnancy and childhood development. Moreover, the presence of pathogenic species, or absence of beneficial species, in early childhood has been suggested to play a key role in the initiation of preterm birth, development of asthma or eczema, allergy, autism or other immunological deficiency. The goal of this study is to better understand the link between maternal and newborn microbiome. Specifically, we will investigate the microbial composition of the stool of newborn babies born to mothers with certain health issues as compared to healthy mothers. This information may help identify the factors that can help better understand the risk transmitted through the microbiome.
By collecting the samples including stools, saliva and understanding the health history of pregnant women with or without Inflammatory bowel disease (IBD), we can compare the data of two groups pregnant women in order to find out the differences of microbiome in their guts. Another aim of our study is finding out the possibility of vertical bacteria transmission from mother to baby.
Furthermore, our main focus is the meconium of newborn baby, we would like to know that the differences of microbiome in the gut between the newborns from two groups. Therefore, we will collect the umbilical cord blood, placenta, amniotic membrane, newborn cheek swab, and meconium. To investigate the disease transmission rate from mothers.
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?: