Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04792918

Acronym

NEC

Enrollment

Registered

2021-03-11

Start date

2021-02-11

Completion date

2023-06-20

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-Onset Neonatal Sepsis, Necrotising Enterocolitis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 3 Days

Healthy volunteers

Inclusion criteria

-Preterm infants with a gestational age \< 32 weeks or a birthweight \< 1500g and their family members

Exclusion criteria

* Intestinal atresia * Live born infants referred to from other hospitals later than 3 days after birth

Design outcomes

Primary

Measure	Time frame	Description
Strain-level stability	24 months	Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm infants via changes in frequencies, absolute colonization levels, or temporal stability

Secondary

Measure	Time frame	Description
Source of bacterial species/strains	24 months	Quantify genetic similarity between potentially disease-causing microbiota strains found within NEC/LOS patients and within family members (faeces, breastmilk, vaginal swab) and hospital surroundings

Countries

Switzerland

Outcome results