NCT04792918

Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Emma Marie Caroline Slack · Academic / Other
• Sex: All
• Age: 0 Days – 3 Days
• Healthy volunteers: Not accepted

Summary

Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.

Detailed description

This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab). The main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.

Conditions

• Necrotising Enterocolitis
• Late-Onset Neonatal Sepsis

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2021-03-11
• Last updated: 2023-07-10

Locations

2 sites across 1 country: Switzerland