Bacterial Transmission In Utero and IBD Risk

Active, not recruiting

• Conditions: IBD; Microbiota; Pregnancy Related

• Registration Number: NCT03116568
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-17
• Study Start: 2017-04-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-04-14
• Study Completion: 2027-09-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Sha Tin, Hong Kong