CClinicalTrials.gg
Sign In
Active, not recruitingNCT03116568Updated Feb 8, 2023

Bacterial Transmission In Utero and IBD Risk

An observational study in IBD, Pregnancy Related and Microbiota, sponsored by Chinese University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged Up to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
180
Ages
Up to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • IBD
  • Pregnancy Related
  • Microbiota

Keywords

  • IBD
  • Meconium
  • Pregnancy
  • Microbiota
  • Newborn
03

In context

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

06

What researchers measure

Primary outcomes

  1. Relation of microbiota in the gut between mother and new-borns

    Identify different type of intestial bacteria between both IBD and Control groups

    Time frame: 5 years after the mother give birth

07

Study locations

1 site
  • The Chinese University of Hong Kong
    Sha Tin, 000000, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03116568
Lead sponsor
Chinese University of Hong Kong
Responsible party
Siew Chien NG (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Apr 17, 2017
Start date
Apr 24, 2017
Primary completion
Apr 14, 2025 (estimated)
Completion
Sep 27, 2027 (estimated)
Last update
Feb 8, 2023

Study contacts

Siew Chien Ng, PhD
principal investigator · Chinese University of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Chinese University of Hong Kong

Start the discussion