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

NCT05112497 | Active Not Recruiting

• 1 other identifier: MoMmy-CD
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crohn Disease

Keywords

Crohn Disease; Gut Microbiota; Mother-baby Cohort

Outcome Measures

Primary Outcomes (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.

  across two years

Secondary Outcomes (1)

• The temporal dynamics of the development of the breast milk microbiota in mothers and infants will be determined

  across two years

Study Arms (2)

Crohn's Disease

1. Pregnant CD patients 2. Newborn of pregnant CD patients 3. Father of the newborn 4. Non-pregnant CD women

Other: No intervention procedure

Healthy Control

1. Pregnant women without CD 2. Newborn of pregnant women without CD 3. Father of the newborn

Other: No intervention procedure

Interventions

No intervention procedure OTHER

No intervention procedure

Crohn's Disease; Healthy Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• First Affiliated Hospital of Kunming Medical University: collaborator
• First People's Hospital of Foshan: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Siew Chien Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: November 9, 2021
• Study Start: June 10, 2020
• Primary Completion: November 10, 2023
• Study Completion: August 10, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)