Bacterial Transmission In Utero and IBD Risk

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03116568

Enrollment

180

Registered

2017-04-17

Start date

2017-04-24

Completion date

2027-09-27

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD, Microbiota, Pregnancy Related

Keywords

IBD, Meconium, Pregnancy, Microbiota, Newborn

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 100 Years

Healthy volunteers

Yes

Inclusion criteria

1. Pregnant Women with IBD (Case) Inclusion Criteria 1. Be pregnant or planning pregnancy 2. To have confirmed IBD 3. To plan giving birth in Hong Kong

Exclusion criteria

1. Pregnancy complications, such as intrauterine fetal demise/stillbirth, preeclampsia, hyperemesis gravidarum, active infection, including chorioamnionitis or sepsis 2. Fetus chromosomal or structural abnormalities 3. Known history of HIV 4. History of Colectomy or ileo-anal pouch 2. Pregnant Women without IBD (Control) Inclusion Criteria 1. To be pregnant or planning pregnancy 2. Subjects without IBD 3. To plan giving birth in Hong Kong

Design outcomes

Primary

Measure	Time frame	Description
Relation of microbiota in the gut between mother and new-borns	5 years after the mother give birth	Identify different type of intestial bacteria between both IBD and Control groups

Countries

Hong Kong

Outcome results