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

Active, not recruiting

• Conditions: Crohn Disease

• Registration Number: NCT05112497
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-5-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Inclusion Criteria for CD patients:<br><br> - To be pregnant in the 1st trimester or planning pregnancy.<br><br> - Diagnosis of Crohn's disease is confirmed by clinical, endoscopic, radiological and<br> histological features<br><br> - All eligible should sign the consent form<br><br>Inclusion Criteria for Healthy Control:<br><br> - To be pregnant in the 1st trimester or planning pregnancy<br><br> - Subjects without a diagnosis of IBD<br><br> - All eligible should sign the consent form<br><br>Inclusion Criteria for non-pregnant CD patients<br><br> - Diagnosis of Crohn's disease is confirmed by clinical, endoscopic, radiological and<br> histological features<br><br> - All eligible should sign the consent form<br><br>Exclusion Criteria for all groups:<br><br> - Co-morbidities, such as type I or type II diabetes, autoimmune diseases, cancer, HIV<br><br> - Inability to give informed consent<br><br> - Probiotics. prebiotics and antibiotics use in the past 3 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The gut metagenomes at the bacteria species level the among different groups will be determined

Secondary Outcome Measures

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