Bacterial Transmission In Utero and IBD Risk

NCT ID: NCT03116568

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2027-09-27

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.

Conditions

IBD; Pregnancy Related; Microbiota

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

IBD Case

1. Pregnant women with IBD

2. Newborns of pregnant women with IBD

3. Family member of pregnant women with IBD

4. Siblings of newborns

No interventions assigned to this group

Control

1. Pregnant women without IBD

2. Newborns of pregnant women without IBD

3. Family member of pregnant women without IBD

4. Siblings of newborns

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Pregnant Women with IBD (Case) Inclusion Criteria 1. Be pregnant or planning pregnancy 2. To have confirmed IBD 3.

Exclusion Criteria

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 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 5. Autoimmune diseases 6. Blood in stools 7. History of perianal fistula or abscesses 3. Family Members Inclusion Criteria 1. Residing in the same household with the pregnant woman from both case and control groups e.g. child, spouse, parents of the pregnant woman 2. The subject or, when applicable, the subject's legally acceptable representative (or parent or legal guardians) signs and dates a written, informed consent form prior to the initiation of study. 4. New Born Baby Inclusion Criteria 1. Be a new born baby of enrolled pregnant women from both case and control groups 2. The subject's parents or legally guardians sign and date a written, informed consent form prior to the initiation of study.

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Siew Chien NG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siew Chien Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

The Meconium Study

Identifier Type: -

Identifier Source: org_study_id