Clinical trial NCT03116568: Bacterial Transmission In Utero and IBD Risk
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IBD
Pregnancy Related
Microbiota
Keywords: IBD
Meconium
Pregnancy
Microbiota
Newborn
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 180
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects include (1) pregnant women with IBD (case), (2) pregnant women without IBD (control), (3) family members of pregnant women from both groups and (4) new born baby of both groups

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.

Eligibility 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 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.

Primary outcomes:
measure: Relation of microbiota in the gut between mother and new-borns
timeFrame: 5 years after the mother give birth
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew Chien Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: