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Crohn DiseaseNCT05112497

Mother-to-Infant Transfer of Bacteriome, Fungome, Virome, and Metabolome in Health and Crohn's Disease

An observational study of Crohn Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Crohn Disease
How many people
480 participants
Where
1 siteHong Kong
Study dates
10 Jun 2020to 10 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: CD: 1. Pregnant CD patient 2. Newborn of pregnant CD patient 3. Father of newborn 4. Non-pregnant CD women Healthy: 1. Pregnant women without CD 2. Newborn of pregnant women without CD 3. Father of newborn

Who may be able to join

  • To be pregnant in the 1st trimester or planning pregnancy.
  • Diagnosis of Crohn's disease is confirmed by clinical, endoscopic, radiological and histological features
  • All eligible should sign the consent form
  • To be pregnant in the 1st trimester or planning pregnancy
  • Subjects without a diagnosis of IBD
  • All eligible should sign the consent form
  • Diagnosis of Crohn's disease is confirmed by clinical, endoscopic, radiological and histological features
  • All eligible should sign the consent form

Who cannot join

  • Co-morbidities, such as type I or type II diabetes, autoimmune diseases, cancer, HIV
  • Inability to give informed consent
  • Probiotics. prebiotics and antibiotics use in the past 3 months

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses. Both CD and UC are difficult to manage clinically, and their incidences are increasing worldwide especially in newly industrialized countries. The etiology of these disorders is multifactorial, influenced by the complex interactions of genes, the immune system, intestinal microbiota, and the external environment. Studies have shown that there is a higher disease transmission rate from mothers with IBD than from fathers. It is well established that IBD is also associated with perturbations of gut microbiota composition. Early childhood is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed. New evidence suggests that the gastrointestinal tract of new-borns becomes colonized with bacteria while in the womb, with the presence of different microbes. The source of these microbes is of continued interest because the initial intestinal colonization is believed to play a crucial role in the priming of the mucosal immune system and may predispose to the development of immune-mediated diseases, such as IBD, later in life. Overall, the microbiome structures in mother-babies across healthy and IBD populations are largely underexplored.

Given the complexity of microbes present in the gestational gut, it will be exciting to learn whether there are other modules of priming induced by distinct microbes and their metabolites. Along these lines, it is tempting to speculate that this transgenerational effect represents a predictive adaptive response whereby mothers prepare the neonates for specific challenges that they are likely to encounter based on gestational environmental cues, not only by microbial colonisation but also by metabolite transfer. Meanwhile, it is unknown whether there are abnormalities in the metabolome and its mother-to-infant transfer in IBD. Those results indicate that the metabolomic profiles are altered in IBD mother's breast milk, which may transfer to infants and influence their development and health.

Read the detailed description

Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses. Both CD and UC are difficult to manage clinically, and their incidences are increasing worldwide especially in newly industrialized countries. The etiology of these disorders is multifactorial, influenced by the complex interactions of genes, the immune system, intestinal microbiota, and the external environment. Studies have shown that there is a higher disease transmission rate from mothers with IBD than from fathers.[47] It is well established that IBD is also associated with perturbations of gut microbiota composition. Early childhood, when the microbiota is less mature and more malleable, is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed. New evidence suggests that the gastrointestinal tract of new-borns becomes colonized with bacteria while in the womb[1], with the presence of different microbes reported in amniotic fluid[2, 3], umbilical cord blood[4], as well as placental and foetal membranes[5, 6]. The source of these microbes is of continued interest because the initial intestinal colonization is believed to play a crucial role in the priming of the mucosal immune system and may predispose to the development of immune-mediated diseases, such as IBD, later in life[7]. Our pilot study on several mother-baby samples showed that at the order level, Caudovirales predominated in the viral communities of breast milk and meconium with relative abundance above 95%. However, in the viral community of placenta, the Caudovirales only occupied approximately 50%, concomitant with the emergence of eukaryotic viruses such as Ortervirles (average 27.5%) and Herpesvirales (average 9.3%). Overall, the microbiome structures in mother-babies across healthy and IBD populations are largely underexplored.

A recent study discovered a novel mechanism of vertically transmitted protection of the new-born. The researchers found that bacteria in the mother's intestine during gestation can drive later innate maturation of the neonatal gut in the absence of colonization, through the transfer of specific bacterial metabolites to the foetus and via mother's milk [8]. Gomez de Agu ero et al. (2016) clearly demonstrated that the effects of the gut microbiota on postnatal immune maturation are not simply due to colonization of the new-born after birth[9]. They show this in a simplified model of gestational monocolonization with E. coli whereby AhR ligands derived from this bacterium drive a distinct early postnatal intestinal developmental program[9]. Given the complexity of microbes present in the gestational gut, it will be exciting to learn whether there are other modules of priming induced by distinct microbes and their metabolites. Along these lines, it is tempting to speculate that this transgenerational effect represents a predictive adaptive response whereby mothers prepare the neonates for specific challenges that they are likely to encounter based on gestational environmental cues, not only by microbial colonisation but also by metabolite transfer. Meanwhile, it is unknown regarding whether there are abnormalities in the metabolome as well as its mother-to-infant transfer in IBD. To address this question, we began with a pilot study on breast milk metablome profiling, employing untargeted metabolomics approach by liquid chromatography-mass spectrometry (LC-MS). The results showed a total of 1,318 Negative-mode features and 1,418 Positive features discriminatory between IBD (4UC, 3 CD) mothers and healthy mothers, indicative of broad metabolic differences between them. Those significantly changed metabolites were involved in arginine and proline metabolism as well as tyrosine metabolism according to pathway enrichment analysis. Those results indicate that the metabolomic profiles are altered in IBD mother's breast milk, which may transfer to infants and influence their development and health.

Conditions
Crohn Disease
Being tested
No intervention procedure
Keywords
Crohn Disease, Gut Microbiota, Mother-baby Cohort
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention procedureOther

    No intervention procedure

Study groups in NCT05112497
Study groupRoleWhat they receive
Crohn's Disease1. Pregnant CD patients 2. Newborn of pregnant CD patients 3. Father of the newborn 4. Non-pregnant CD women
Receives: Other: No intervention procedure
Healthy Control1. Pregnant women without CD 2. Newborn of pregnant women without CD 3. Father of the newborn
Receives: Other: No intervention procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The gut metagenomes at the bacteria species level the among different groups will be determined

    Metagenomic sequencing will be used to evaluate the heterogeneities of the bacteria species among different groups.

    Measured: across two years

Secondary outcomes (1)
  1. The temporal dynamics of the development of the breast milk microbiota in mothers and infants will be determined

    Metagenomic sequencing will be used to evaluate the heterogeneities of the bacteria species of breast milk in mothers and infants.

    Measured: across two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start10 Jun 2020
  3. Primary completion10 Nov 2023
  4. Study completion10 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112497
Sponsor's protocol ID
MoMmy-CD
Status last verified
Aug 2024
First submitted
5 May 2021
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The gut metagenomes at the bacteria species level the among different groups will be determined (time frame: across two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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